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. 2016 Jul 8;2016(7):CD010735. doi: 10.1002/14651858.CD010735.pub2

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"
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
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)