Brown 1996.
Methods | Study design: Parallel group RCT | |
Participants |
Country: USA Setting: Eye hospital Intervention group: NSAIDs alone
Comparator: Steroids alone
Inclusion criteria: Undergoing phacoemulsification with posterior capsular opacification after lens (PCOL) implantation. Exclusion criteria: History of systemic or ocular inflammation (iritis, uveitis); taking oral or ophthalmic steroids or NSAIDs; other ocular disease such as glaucoma, corneal disease, or diabetic retinopathy. Pretreatment: Group differences not reported. Eyes: Unclear if one or both eyes included. |
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Interventions |
Intervention group: NSAIDs alone
Comparator: Steroids alone
All patients had gentamicin drops for 7 days postoperative. Type of surgery: Phacoemulsification |
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Outcomes |
Follow‐up: 1 month
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Contact details |
Authors name: Rose Marie Brown Institution: New York Hospital ‐ Cornell Medical Center Email: NR Address: Cornell University Medical College, 520 E. 70th St, Starr 817, New York, NY 10021 |
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Notes |
Funding sources: "Supported in part from a grant from Ciba Vision Ophthalmics, Duluth, Ga." Declaration of interest: NR Date study conducted: 1991 Trial registration number: NR Contacting study investigators: Trial authors not contacted. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote "We conducted a prospective, randomised study." "The patients were randomly assigned to receive..." Judgement comment: Not reported how list was generated. Study was described as “randomised” but with no further details. |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: Not reported how allocation administered. Study was described as “randomised” but with no further details. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: No information on masking. We assume that in absence of reporting on this, patients and personnel were not masked. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: For measurement of inflammation ‐ Quote: "Neither examiner knew which of the study groups the patient was enrolled in." But for other outcomes, masking not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: Follow‐up not reported. Unclear how many people seen at 1 month. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: No access to protocol or trials registry entry. |