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Manual small incision cataract surgery (MSICS) with posterior chamber intraocular lens versus phacoemulsification with posterior chamber intraocular lens for age-related cataract

  1. Yasmin Riaz1,
  2. Samantha R de Silva1,
  3. Jennifer R Evans2,*

Editorial Group: Cochrane Eyes and Vision Group

Published Online: 10 OCT 2013

Assessed as up-to-date: 23 JUL 2013

DOI: 10.1002/14651858.CD008813.pub2


How to Cite

Riaz Y, de Silva SR, Evans JR. Manual small incision cataract surgery (MSICS) with posterior chamber intraocular lens versus phacoemulsification with posterior chamber intraocular lens for age-related cataract. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD008813. DOI: 10.1002/14651858.CD008813.pub2.

Author Information

  1. 1

    Oxford Eye Hospital, Oxford, UK

  2. 2

    London School of Hygiene & Tropical Medicine, Cochrane Eyes and Vision Group, ICEH, London, UK

*Jennifer R Evans, Cochrane Eyes and Vision Group, ICEH, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. jennifer.evans@lshtm.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 10 OCT 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Cook 2012

MethodsParallel group randomised controlled trial

200 participants (200 eyes) randomised

Follow-up: eight weeks


ParticipantsAge-related cataract in participants over 50 years

Exclusion criteria:

1. People with early cataract (visual acuity better than 6/36)

2. People with coexistent glaucoma

3. People with corneal scar

Demographics:

M:F phacoemulsification 39:61; MSICS 33:67

Mean age: phacoemulsification 66.9 years, MSICS 68.8 years

Black, coloured and white participants

Setting:

Groote Schuur Hospital, University of Cape Town, South Africa


InterventionsMSICS n = 100; phacoemulsification n = 100


Outcomes
  1. UCVA at day 1 and week 8
  2. BCVA at week 8
  3. Refraction
  4. Intraoperative and postoperative complication


NotesPublished data only

Date conducted: not reported

Funding sources: "Nil"

Declarations of interest among the primary researchers: "Nil"


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomisation to the two arms of the study was done using opaque sequentially numbered envelopes. The randomisation sequence allocation was generated by a research assistant who randomly selected and numbered sequential envelopes containing an instruction on the type of surgery to be done".

Allocation concealment (selection bias)Low risk"The envelopes were kept in the operating room, and the next numbered envelope was opened by the surgeon immediately prior to the surgery".

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"The patients were not informed about the method of surgery that was used"

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"The ophthalmic assistants and nurses who tested and recorded the post operative visual acuities were also masked to the surgery that was done"

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk80 participants in the phacoemulsification group, 85 participants in the MSICS group completed 8-week follow-up. "Eighteen per cent of our patients were lost to follow-up at eight weeks. Our patients are indigent people living both within the Cape Town Metropole and in more distant rural areas, and this loss to follow-up is difficult to control".

Selective reporting (reporting bias)Low riskNone obvious.

George 2005

MethodsParallel group randomised controlled trial

124 participants (124 eyes) randomised by computer-generated random numbers

Follow-up: six weeks


ParticipantsPrimary diagnosis of nuclear sclerosis grade III or less

Exclusion criteria:

1. Persons with other potential causes of decreased vision

2. Non-age-related cataracts

3. Cataract associated with glaucoma or retinal pathology

4. Phacodenesis

Demographics:

Gender M:F ratio 24:29 for MSICS, 27:33 for phacoemulsification groups. Mean age 58.75 years for MSICs and 59.63 for phacoemulsification groups (no significant difference in the age or gender of all three groups)

Study setting:

Community ophthalmic care centre of a tertiary care eye hospital, Tamil Nadu, India


InterventionsMSICS n = 62; phacoemulsification n = 62 (ECCE group n = 62, not included in this review)


Outcomes
  1. Mean endothelial cell loss
  2. Cell density recorded as no of cells per square millimetre and as a percentage reduction
  3. Mean surgically induced astigmatism (dioptres)
  4. Mean prescribed cylindrical correction (dioptres)
  5. Postoperative BCVA < 6/18


Participants were reviewed preoperatively, at one day, one week and six weeks postoperatively. Only results from the preoperative and six weeks postoperative visits were reported

At six weeks all participants had visual acuity measured, refraction, slit lamp examination, keratometry, applanation tonometry, specular microscopy and dilated fundus examination

The six-week follow-up was completed on 52/62 cases in the ECCE group, 53/62 cases in the MSICS group and 60/62 cases in the phacoemulsification group

No subgroup analyses were performed.


NotesPublished data only

Date conducted: not reported

Funding sources: none specified

Declarations of interest among the primary researchers: not mentioned


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Cases were randomized into three groups based on computer-generated random numbers. Randomization was carried out at the time of admission and used the hospital numbers (which were allotted at the time of the first hospital visit) for allocation into different groups". (Page 294)

"Cases were separately randomized for each surgeon so that equal numbers of each technique were performed by each surgeon". (Page 294)

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskStudy does not document whether participants were aware/ informed of which intervention they were assigned to

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"Independent observers performed refraction and keratometry in order to minimize bias". (Page 295)

No mention of masking of outcome assessment

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskThe six-week follow-up was completed by 53/62 cases of MSICS and 60/62 cases of phacoemulsification

The reasons for attrition were not stated

Selective reporting (reporting bias)Unclear riskPrimary outcomes implicit but neither outcomes or protocol clearly stated.

Ghosh 2010

MethodsParallel group randomised controlled trial

224 participants (224 eyes) randomised. “In each patient, the eye with more advanced cataract was included as study eye” (Page 103).

Follow-up: six months


ParticipantsInclusion criteria:

Age 50 - 75 with age-related cataract

Exclusion criteria:

Fasting plasma glucose more than 126 mg/dl

Any treatment history of diabetes

History of previous eye surgery

Present or past history of uveitis
Ocular disease other than cataract
History of significant eye trauma
Axial length more than 26.5 mm

People with 3+ or more flare (Standardization of Uveitis Nomenclature Working Group) on the 1st postoperative day were also excluded from study.

Demographics:

Mean age: 62 +/- 6 SD years MSICS group; 61 +/- 6 SD Phacoemulsification group

Males: 125 participants (55.8%)

Study setting:

Tertiary care hospital, Kolkata, West Bengal, India


InterventionsMSICS n = 112; phacoemulsification n = 112


Outcomes
  1. BCVA
  2. Mean macular thickness


NotesPublished data only

Date conducted: April 2007 to April 2008

Funding sources: none specified

Declarations of interest among the primary researchers: not mentioned


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Each patient was allocated to either MSICS or phacoemulsification group by drawing ballots from a sealed envelope". (Page 103)

Allocation concealment (selection bias)Low risk"Allocation to each surgeon was also performed during drawing of ballots, the two procedures being equally distributed among two surgeons (PNB, SG)". (Page 103)

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"The participating surgeons were not involved with the allocation procedure and were masked concerning the method of surgery until the patients were prepared on the table. The patients were masked to the allocation code until surgery was performed". (Page 103)

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDetails not stated in paper

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"All patients completed the 1st-day and the 7th-day follow-up. In phacoemulsification group, 97 patients came for the 42nd-day follow-up and 94 patients completed the 180th-day follow-up. In MSICS group, 100 patients completed the 42nd-day follow-up and 99 came for the 180th-day follow-up". (Page 103).

Reason for attrition not stated.

Selective reporting (reporting bias)High risk"Five patients in MSICS group (corneal oedema 1, iridodialysis 1, posterior capsular rupture 1, sulcus fixation IOL 1, 3+ flare 1) and nine patients in phacoemulsification group (corneal oedema 4, posterior capsular rupture 4, 3+ flare 1) were further excluded from the study because of various preoperative and postoperative complications necessitating alteration in management protocol". (Page 103)

"The macular thickness of the five cases that were excluded for corneal oedema was evaluated on the 42nd and the 180th day after clearance of oedema. When these values along with the values of two patients with 3+ flare and five patients with capsular rupture were included in the analysis, the difference in CSMT between the two groups was still statistically significant". (Page 104).

Gogate 2005a

MethodsParallel group randomised controlled trial

400 participants (400 eyes) randomised

Follow-up: six weeks


ParticipantsPrimary diagnosis: age-related cataract

Inclusion criteria:

Resident in region, willing and able to attend regular follow-up for one year

Exclusion criteria:

Combined surgical procedure

Other causes of compromised vision (e.g. amblyopia, glaucoma, diabetic retinopathy, age-related macular degeneration)

Axial length > 26.5 mm

Age < 40 or > 90

Age/mobility would hinder follow-up

Could not give informed consent

Demographics: age 40 - 90, average age 68.1 phacoemulsification, and 60.7 for MSICs.

Study setting:

HV Desai Eye hospital, Pune, India


InterventionsMSICS n = 201; phacoemulsification n = 199


OutcomesRelevant outcomes:

  1. VA at one week and six weeks
  2. Intraoperative and postoperative complications
  3. Final astigmatism at six weeks postoperative


Adverse events: two phacoemulsification converted to MSICs

Intervals of outcomes: one and six weeks

Number of participants included in analysis:

Phacoemulsification at one week follow-up = 192, at six weeks follow-up = 185

MSICs at one week follow-up = 191, at six weeks follow-up = 187


NotesPublished data only

Date conducted: July 2002 to December 2003.

Funding sources: HV Desai hospital and Lakhani Trust

Declarations of interest among the primary researchers: not mentioned


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation of participants: "Each patient was randomly allocated to 1 of the 2 groups by drawing ballots (from sealed envelopes) at the beginning of surgery, after the patient was placed on the operating table". (Page 870)

Allocation concealment (selection bias)Low riskThe allocation codes were sealed in sequentially numbered opaque envelopes and placed in the care of the trial manager. The participating surgeons were not involved in the care of or the opening of the envelopes and were informed of the treatment assignment in the operating room immediately before surgery. The trial statistician who generated the allocation schedule in Hyderabad was not involved in the execution of the assignment. The trial manager opened the envelope in Pune and was not involved in the generation of the allocation schedule." (Page 870)

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"The patients were masked before, during, and after (during the follow-up) the surgical intervention regarding the surgical technique. The patients and the ophthalmologists in charge of the follow-up outcome assessment were masked to the treatment allocation code.". (Page 870)

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"The patients and the ophthalmologists in charge of the follow-up outcome assessment were masked to the treatment allocation code. However, the ophthalmologist examining the patient on follow-up would be able to determine the type of surgery". (Page 870)

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo reasons for attrition were reported. 185/199 completed follow-up in the phacoemulsification group and 187/201 completed follow-up in the MSICs group.

Selective reporting (reporting bias)Unclear riskNone obvious.

Gogate 2010

MethodsParallel group randomised controlled trial

200 participants randomised: it is most likely that one eye per person was enrolled in the trial; it was unclear how this eye may have been selected

Follow-up: six weeks


ParticipantsPrimary diagnosis: age-related cataract

Inclusion criteria:

Mature cataract

Cataract up to grade 4 hardness

Exclusion criteria:

Ocular comorbidity e.g. acute infection, severe inflammation, pre-existing corneal opacity, black cataract, non-age-related or complicated cataract, glaucoma, pseudoexfoliation, retinal pathology

Pre-operative endothelial cell count < 2000 cells/mm2

Unable to consent

Demographics:

Gender 47.5% male, mean age 63.7 years for phacoemulsification and 62.7 for MSICs

Study setting:

Tertiary care centre, India


InterventionsMSICS n = 100; phacoemulsification n = 100


Outcomes1. Endothelial cell count - Preoperatively, one week, and six weeks postoperatively

2. Difference in ECCE over time

3. Corrected distance VA at one and six weeks

4. Intra- and postoperative complications up to six weeks

5. Postoperative astigmatism

Number of participants included in the analysis:
at one week, phacoemulsification 92/100, MSICs 94/100.
at six weeks phacoemulsification 71/100, MSICs 75/100

Adverse events were reported for both groups


NotesPublished data only

Date conducted: not reported

Funding sources: none specified

Declarations of interest among the primary researchers: "no author has a financial or proprietary interest in any material or method mentioned"

No correspondence with authors


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Ballots drawn from sealed envelopes at beginning of surgery used to randomly allocate each patient to phacoemulsification or SICS. There were 50 ballots for each of 4 surgeons; 25 ballots were for SICS and 25 for phacoemulsification. The randomization (allocation) schedule for each surgeon was generated using the EpiTable application (Epi Info, Centers for disease control) at the International Centre for Advancement and Rural Eye Care, L.V. Prasad Eye Institute, Hyderabad, India." (Page 248)

Allocation concealment (selection bias)Low risk"The allocation codes were sealed in sequentially numbered, opaque envelopes and kept by the study coordinator. The envelopes were opened 10 minutes before surgery. The participating surgeons were not involved in the care or opening the envelopes. If the surgeons performed a different technique or converted from phacoemulsification to SICS, the patients were analyzed on an intent to treat basis". (Page 248)

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"To minimize bias, patients were masked to the type of surgery". (Page 248)

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"Health workers interviewing patients were also unaware of the type of surgery the patients were to have. Surgeons were masked to the technique until 10 minutes before surgery. Optometrists and ophthalmologists examining the patient postoperatively were not masked to the type of surgery.A different set of ophthalmologists performed the postoperative follow-up and refractions". Page 248

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo explanation is given of why the attrition rate was relatively high.

"However, patients whose data were not available (lost to follow-up, data lost) did not differ from those whose data were available in preoperative variables (age, sex, preoperative acuity, cataract type, operating surgeon), intraoperative variables (type of surgery, surgery time, complications), or 1-week follow-up outcome measures". (Page 251)

Missing data balanced in numbers across intervention groups. 71/100 participants analysed for phacoemulsification group and 75/100 analysed for MSICs group.

Selective reporting (reporting bias)Unclear riskNone obvious

Ruit 2007

MethodsParallel group randomised controlled trial

108 participants randomised: it is most likely that one eye per person was enrolled in the trial; it was unclear how this eye may have been selected

Follow-up: six months


ParticipantsPrimary diagnosis: decreased visual acuity due to cataract

Exclusion criteria:

Other ocular disease

Demographics:

Median age 65.8 years (phacoemulsification) 63.8 years (MSICS)

Study setting:

Outreach microsurgical eye clinic, Nepal


InterventionsMSICS n = 54; phacoemulsification n = 54


OutcomesOutcomes:

  1. Operation time
  2. Surgical complications intraoperatively and postoperatively
  3. UCVA and BCVA
  4. Astigmatism
  5. Central corneal thickness and keratometry
  6. Cost of equipment and consumables


Intervals at which outcomes assessed:

Postoperative days one and five, three and six weeks, three and six months

Adverse events were reported for each intervention

Number of participants included in analysis:

100% follow-up for each intervention at day one postoperatively

phacoemulsification 86%; MSICs 85% follow-up at six months


NotesPublished data only

Date conducted: May 2005

Funding sources: none specified

Declarations of interest among the primary researchers: "The authors indicate no source of funding or financial conflict of interest"

No correspondence with investigators


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Patients who were cleared for cataract surgery were assigned randomly by picking a ball from a bag that contained one white ball and one black ball. A white ball assigned the patient to phacoemulsification with a foldable IOL, which was performed by one of the authors (D.C.), who is a clinical professor at the University of California, San Francisco. A black ball assigned the patient to sutureless manual SICS, which was performed by another author (S.R.), director of the Tilganga Eye Center in Nepal. After each random assignment, the following patient was assigned automatically to the alter- native procedure". (Page 33)

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskSurgeons were not masked since each surgeon performed a different technique

Not mentioned if participants were masked

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"All postoperative visual acuities and refractions were obtained by ophthalmic assistants who were masked to the treatment group and had not been involved in the preoperative portion of the study." (Page 34)

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCause of attrition rate not known:

"Because of the nature of the outreach cataract screening process and the poor and remote setting where most patients reside, we were unable to determine the reasons that eight patients in the manual SICS group and six patients in the phacoemulsification group were lost to follow-up". (Page 35). 48/54 patients analysed for phacoemulsification group and 46/54 analysed for MSICS group

Selective reporting (reporting bias)Unclear riskNone obvious

Singh 2009

MethodsParallel group randomised controlled trial

182 participants randomised: it is most likely that one eye per person was enrolled in the trial; it was unclear how this eye may have been selected

Follow-up: immediate postoperative (before discharge) only


ParticipantsInclusions criteria:

People with immature senile cataracts (defined as nucleus sclerosis up to 2+, cortical cataract 2+ and posterior sub-capsular cataract of any grade).

Exclusion criteria:

All other types of cataracts were excluded.

Demographics:

Mean age 58.2 years (phacoemulsification), 58.7 years (MSICS)

Study setting:

Biratnagar Eye Hospital, Nepal


InterventionsMSICS n = 89; phacoemulsification n = 93


Outcomes
  1. Postoperative uncorrected visual acuity on the first postoperative day
  2. Surgery-induced astigmatism
  3. Intraoperative and postoperative complications
  4. Surgical time


NotesPublished data only

Date conducted: May 2007 to June 2007

Funding sources: none

Declarations of interest among the primary researchers: "none"


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomization was done with the help of random number tables". (Page 96)

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot reported

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"However, the visual acuity recording person was not aware of the study and masking could be achieved". (Page 96)

Incomplete outcome data (attrition bias)
All outcomes
Low riskThere is no indication in the paper that any participant did not complete the follow-up period (one day)

Selective reporting (reporting bias)Low riskNone obvious

Venkatesh 2010

MethodsParallel group randomised controlled trial

270 participants randomised: it is most likely that one eye per person was enrolled in the trial; it was unclear how this eye may have been selected

Follow-up: six weeks


ParticipantsInclusion criteria:

Participants between 35 years and 70 years of age with white cataract that obscured fundus visualisation and whose pupils dilated to at least 5.0 mm.

Exclusion criteria:

Subluxated cataracts and cataracts clearly caused by trauma
Additional exclusion criteria
Coexisting glaucoma

Corneal pathology

Uveitis

Poor pupil dilation (!5.0 mm)

Other known pathology that could impair visual potential

People that were unable to attend the follow-up visits or give informed consent

Demographics:

M:F phacoemulsification group 57:76; 51:86 MSICS group

Mean age: 56 +/- 9.3 years phacoemulsification group; 56.6 +/- 9.5 years MSICS group

Setting:

Aravind Eye Hospital, Pondicherry, India


InterventionsMSICS n = 137; phacoemulsification n = 133


Outcomes
  1. Rate of intraoperative and postoperative complications
  2. BCVA
  3. Corneal astigmatism 6 weeks postoperatively
  4. Surgical time


NotesPublished data only

Date conducted: September 2007 to April 2008

Funding sources: none specified

Declarations of interest among the primary researchers: "no author has a financial or proprietary interest in any material or method mentioned"


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The randomization (allocation) schedule was generated by a DOS-based software program at Lions Aravind Institute for Community Ophthalmology". (Page 1850)

Allocation concealment (selection bias)Low risk"The allocation codes were sealed in opaque numbered envelopes that were opened by the operating room staff". (Page 1850)

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Patients were not informed about the method of surgery to which they were assigned". (Page 1850)

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"The evaluating independent investigator (an ophthalmologist who was not a study surgeon) and the examining refractionist who assessed uncorrected (UDVA) and corrected (CDVA) distance visual acuities were also masked to the identity of the operating surgeon and the method of surgery". (Page 1850)

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"Two hundred thirty of 270 patients (85.2%) completed the 6-week follow-up". (Page 1851).
No explanation given for attrition rate

Selective reporting (reporting bias)Low riskNone obvious

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Cai 2008Participants were not randomised to interventions

Centurion 1999All participants underwent phacoemulsification

Centurion 2005Retrospective study

Chanis 1993No direct comparison

Elkady 2009The study reported on microincision cataract surgery (MICS) versus microcoaxial phacoemulsification

Goel 2012Cataract surgery with implantation of endocapsular supporting devices.

Parmar 2006This was a study of per-operative contamination of the anterior chamber

Reddy 2007Non-standard interventions were used

 
Comparison 1. MSICS versus phacoemulsification

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Good functional vision at 3 months (uncorrected acuity)3767Risk Ratio (M-H, Random, 95% CI)0.90 [0.84, 0.96]

 2 Good functional vision at 12 months (uncorrected acuity)Other dataNo numeric data

 3 Good functional vision at 3 months (best-corrected acuity)61223Risk Ratio (M-H, Random, 95% CI)0.99 [0.98, 1.01]

 4 Good functional vision at 12 months (best-corrected acuity)Other dataNo numeric data

 5 Poor visual outcome at 3 months (best-corrected acuity worse than 6/60)61223Peto Odds Ratio (Peto, Fixed, 95% CI)2.48 [0.74, 8.28]

 6 Poor visual outcome at 12 months (best-corrected acuity worse than 6/60)Other dataNo numeric data

 7 Posterior capsular rupture81708Peto Odds Ratio (Peto, Fixed, 95% CI)1.07 [0.63, 1.83]

 8 Iridodialysis51114Peto Odds Ratio (Peto, Fixed, 95% CI)2.37 [0.54, 10.45]

 9 Capsulorhesis extended3708Peto Odds Ratio (Peto, Fixed, 95% CI)0.26 [0.05, 1.30]

 10 Postoperative inflammation3732Peto Odds Ratio (Peto, Fixed, 95% CI)1.19 [0.36, 3.93]

 11 Corneal oedema postoperatively61476Peto Odds Ratio (Peto, Fixed, 95% CI)0.58 [0.41, 0.83]

 12 Corneal oedema 3 to 6 weeks4Peto Odds Ratio (Peto, Fixed, 95% CI)Totals not selected

 13 Posterior capsule opacification2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 14 Endothelial cell loss2Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Analysis 1.2 Comparison 1 MSICS versus phacoemulsification, Outcome 2 Good functional vision at 12 months (uncorrected acuity).
Good functional vision at 12 months (uncorrected acuity)

Study

Ruit 2007At 6 months: MSICS: 41/46 Phacoemulsification: 40/48 Risk ratio: 1.07 (95% CI 0.91 to 1.26)

 
Analysis 1.4 Comparison 1 MSICS versus phacoemulsification, Outcome 4 Good functional vision at 12 months (best-corrected acuity).
Good functional vision at 12 months (best-corrected acuity)

Study

Ruit 2007At 6 months: MSICS: 45/46 Phacoemulsification: 47/48 Risk ratio: 1.0 (95% CI 0.94 to 1.06)

 
Analysis 1.6 Comparison 1 MSICS versus phacoemulsification, Outcome 6 Poor visual outcome at 12 months (best-corrected acuity worse than 6/60).
Poor visual outcome at 12 months (best-corrected acuity worse than 6/60)

Study

Ruit 2007At six months: BCVA < 6/18 1.9% participants in both groups

 
Summary of findings for the main comparison.

Manual small incision cataract surgery (MSICS) compared with phacoemulsification for age-related cataract

Patient or population: people with age-related cataract

Settings: hospital

Intervention: manual small incision surgery

Comparison: phacoemulsification

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

PhacoemulsificationMSICS

Good functional vision (presenting visual acuity 6/12 or better) 12 months after surgerySee commentNo study reported presenting visual acuity; few studies reported 6/12 outcomes; only one study reported at 12 months.

Seven studies reported best-corrected visual acuity (BCVA) of 6/18 or better at three months (pooled RR 0.99 (95% CI 0.98 to 1.01)) and three studies reported uncorrected visual acuity (UCVA) of 6/18 or better at three months (pooled RR in favour of phacoemulsification 0.90 (95% CI 0.84 to 0.96).



Poor visual outcome (best-corrected visual acuity worse than 6/60) 12 months after surgery1 per 100012 per 1000

(1 to 8)
OR: 2.48 (95% CI 0.74 to 8.28)1250
(6)
⊕⊝⊝⊝
very low2,3,4
No data available at 12 months so data from three months follow-up used.

Posterior capsule opacification 12 months after surgerySee comments494

(2)
⊕⊝⊝⊝
very low4,5,6
Posterior capsule opacification was reported in two studies. At six weeks no cases were observed in Gogate 2005a and at six months 20/46 MSICS versus 7/48 phacoemulsification cases were observed in Ruit 2007 (OR 2.98, 95% CI 1.39 to 6.37).





Other complicationsSee commentsNo data on retinal detachment, glaucoma, cystoid macular oedema or corneal decompensation.



Quality of life See commentsNo data reported



CostsSee commentsIn the Ruit 2007 study, phacoemulsification cost USD 70 per case and MSICS cost USD 15 per case.



*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio; OR: Odds Ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Risk in phacoemulsification group ranged from 0 per 1000 to 25 per 1000 in the included studies; the median risk was 0. We have therefore estimated a low risk in the phacoemulsification group at 1 per 1000.
2 Downgraded for risk of bias: several items on risk of bias assessment not clearly reported.
3 Downgraded for imprecision: wide confidence intervals.
4 Downgraded for indirectness (not measured at 12 months).
5 Downgraded for inconsistency: only one study reported so not possible to assess.
 
Table 1. Outcome reporting matrix

 George 2005Gogate 2005Gogate 2010Ruit 2007Singh 2009Cook 2012Venkatesh 2011Ghosh

2010

Review outcomes         

Presenting VA ≥ 6/12HHIH

BCVA < 6/60FFI

Capsular rupture with or without vitreous loss

Iris prolapseHHHHHHH

Postoperative inflammationHHHH

Posterior capsule opacificationHHHHHH

Retinal detachmentHHHHHHHH

GlaucomaFHHHHHHH

Cystoid macular oedemaHHHHHHH

Corneal endothelial cell lossHHHHHH

Corneal decompensationHHHHHHHH

Quality of lifeIIIIIIII

Other outcomes

(list other outcomes reported)
AstigmatismCapsulorhexis extended, Iridodialysis, zonule dialysis, Descemet tear, conversion to MSICS, AstigmatismCapsulorhexis extended, Conversion to MSICS, Iridodialysis, retained cortex, decentred IOLCapsulorhexis extended, Minor hyphaema, cost effectiveness, AstigmatismZonule dialysis, surgical time, Astigmatism“Other complications”, corneal oedema at day 1, median astigmatismCorneal oedema at day 1 and 6 weeks, astigmatism, surgical timeMacular thickness

 ✔ Reported and included in review
F: Clear that outcome was measured but not necessarily analysed. Judgment says unlikely to have been analysed but not reported because of non-significant results (low risk of bias)
H: Not mentioned but clinical judgment says unlikely to have been measured at all (low risk of bias)
I: Clear that outcome was not measured (no risk)
For other categories see Kirkham 2010