Conrad‐Hengerer 2013
| Methods | Within‐person (paired‐eye) RCT | |
| Participants | Number of participants randomised: 75 Number of eyes included: 150 Country: Germany Average age: 71 years Sex: 63% female Ethnic group: not described Inclusion criteria: "All patients enrolled had a visually significant cataract, dilated pupil width of 6.0 mm or larger, and were willing to volunteer for the trial after giving informed consent" Exclusion criteria: "The exclusion criteria included a history of serious coexisting ocular disease, uncontrolled glaucoma, optic atrophy or ocular tumors, use of topical or systemic steroids or nonsteroidal anti‐inflammatory drugs (NSAIDs) during the previous 3 months, relevant corneal opacities, poorly dilating pupils (pupil % 6.0 mm), known zonular weakness, age less than 22 years, or participation in another clinical study" |
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| Interventions | Laser‐assisted cataract surgery using the Catalys platform (Catalys Precision Laser System, AMO) or manual phacoemulsification using a Stellaris phaco machine (Bausch & Lomb) | |
| Outcomes | Primary outcome measures: Corneal endothelial cell loss and corneal thickness at up to 3 months. Additional data reported: effective phacoemulsification time, mean irrigation fluid volume, mean surgical time, intraoperative and postoperative complications | |
| Notes | Funding source: not reported Declaration of interest: "Dr. Dick is a member of the medical advisory board of OptiMedica Corp" Date study conducted: February 2012 to July 2012 Trial registration number: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The method of sequence generation is not described |
| Allocation concealment (selection bias) | Unclear risk | "the surgeon opened the corresponding envelope, receiving information about the procedure to use in each eye; that is, femtosecond laser ‐ assisted or standard phacoemulsification" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Surgeon masking is not feasible; no efforts to mask participants are described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All patients had a full clinical examination by the same masked trained technician" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two patients were excluded at the 3‐month follow‐up because they missed their previous visits. One patient had cancer and was not available for further visits; the other moved to another county" |
| Selective reporting (reporting bias) | Unclear risk | No access to study protocol or trials registry entry (trial was not registered) |