Alió 2002.
| Methods |
Study design: parallel-group RCT Number randomized: not reported Number analyzed: 140 participants Unit of analysis: individual (1 eye per participant) Length of follow-up: 1 year Sample size calculation: not reported |
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| Participants |
Enrollment: 5-15 people enrolled at each study center (19 international centers) Gender: 64 (46%) men and 76 (54%) women were enrolled and completed the 1-year follow-up exam Age: ≥ 18 years Inclusion criteria: people with uveitis in good general health and willing to complete all required postoperative visits; uveitis in quiescence for 3 months; 18 years or older; and able to comprehend and sign a statement of informed consent Exclusion criteria: amblyopia; corneal dystrophy, scars, or vision-impairing disorders; congenital, traumatic, or rubella cataract; a congenitally abnormal cornea; diabetic retinopathy with macular compromise; macular edema; history of retinal detachment in past 6 months; uncontrolled glaucoma; microphthalmus; nonsighted or absent fellow eye; advanced or total optic atrophy; previous corneal transplant or ocular surgery; aniridia; burn-out uveitis; endothelial cell count less than 1500 cells/mm2; Fuchs cyclitis; juvenile rheumatoid uveitis; congenital abnormalities of the anterior segment; posterior uveitis not active in the anterior segment or major iridadenosis indicating large zonular dialysis; and intraoperative vitreous loss and vitrectomy, anterior chamber hyphema, posterior capsule tear, extensive zonular dehiscence or capsulotomy |
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| Interventions |
4 lens types:
Not all study centers had access to each of the 4 study lenses; randomization was based on the availability of lenses at each center. In order to keep enrollment balanced among study centers, each center contributed a minimum of 5 participants and maximum of 15 participants |
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| Outcomes | BCVA, postoperative inflammation, PCO relapses, and other clinical observations (i.e. corneal edema, cystoid macular edema, pupillary membrane crossing, posterior synechiae, giant and small cells on the IOL optic, pigment deposits, IOL decentration, PCO) Exams were performed at 1-2 days, 3-4 days, 6-8 days, 13-17 days, 27-33 days, 80-100 days (3 months), 170-190 days (6 months), and 11-13 months (1 year) |
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| Notes |
Funding source: the International Ocular Inflammation Society Declarations of interest: “None of the authors or members of the International Ocular Inflammation Society has a financial or proprietary interest in any material or method mentioned” |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “Randomization was effected at the multicenter trial data coordination center (Alicante, Spain), in complete block design with IOL assignment in sequentially numbered, sealed envelopes” “Different causes made it impossible to ensure the availability of all lenses for all investigators; thus, each center had an individual randomized protocol for the available IOL following the same randomization code but excluding lenses that were not available. At least 3 of the 4 models were available at all institutions” |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed by use of “sequentially numbered, sealed envelopes. Each patient entering the study was assigned to receive the lens implant designated for his or her patient entry number (e.g., patient #5 received the lens implant described on the randomization card in envelope #5)” |
| Masking (performance bias and detection bias) | High risk | The trial was unmasked |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | “Of the 170 patients considered for the study, 140 fulfilled the enrollment criteria and completed a 1-year follow-up” The study authors did not report whether there were enrolled participants who were lost to follow-up before 1 year (and thus not represented in this report) or if some method was used to account for missing data if lost before 1 year |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to determine (no study protocol available) |
| Other bias | Unclear risk | Insufficient information to determine |