Gogate 2003.
| Methods | Randomised clinical trial: ECCE and MSICS | |
| Participants | 741 participants Age: 40 to 90 years Inclusion criteria: cataract participants within age 40 to 90 years old Exclusion criteria: any ocular co‐morbidity capable of compromising vision, if they needed combined surgical procedures, or if the axial length of the eye was more than 26 mm |
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| Interventions | ECCE versus MSICS Follow‐up: one week, six weeks, and one year after surgery |
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| Outcomes | Visual acuity Primary outcome was the proportion of participants having uncorrected and corrected visual acuity of 6/18 or better at 6 weeks by both techniques Secondary outcomes: 1. Complications, both intraoperative and postoperative, with either technique 2. The average surgical time for each technique 3. Vision related quality of life, patient satisfaction, and economic outcomes |
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| Notes | Randomisation and blinding/masking of outcome assessment clearly described in Methods | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Each patient was randomly allocated to one of the two groups by drawing lots (ballots). There was always a 50% chance of the patient getting one particular kind of intervention." Page 669 |
| Allocation concealment (selection bias) | Low risk | "The operating surgeons also drew ballots for the type of surgery they were supposed to do that day, at the beginning of the theatre list immediately before scrubbing. This random assignment was done in the presence of the anaesthetist, operation theatre senior nurse, and another non‐operating ophthalmologist." Page 669 |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The patients were not informed as to the type of intervention they would receive, in the OT and during follow up. The surgeons were unaware until scrubbing up which surgery they would perform that day. They were also unaware which patient would be brought to them for surgery and did not examine the patients the next day." Page 669 |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Internee doctors and optometrists did postoperative visual acuity testing and administering the questionnaires. They were not told about the type of surgery done." Page 669 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 706/741 completed follow‐up. ECCE group 362/383 (94.5%) and MSICS group 344/358 (96.1%). Figure 1 page 668 |
| Selective reporting (reporting bias) | Unclear risk | None obvious |
| Other bias | Unclear risk | Some surgeons performed more surgeries of one kind if the operating list was more compared to the other technique when the list was shorter. This was done to increase the external validity of the study. Imbalance of surgeon assignment may have introduced bias, but this was dealt with by stratification by surgeon in the analysis |