BACKGROUND: To determine whether a randomized clinical trial, the Infant Aphakia Treatment Study, comparing intraocular lens (IOL) implantation with contact lens (CL) correction for infants with a unilateral congenital cataract (UCC), is feasible by (1) ascertaining whether American Association for Pediatric Ophthalmology and Strabismus (AAPOS) members have equipoise regarding these two treatments and (2) evaluating the willingness of parents to agree to randomization. METHODS:All AAPOS members were surveyed in August 1997 and again in June 2001 regarding their use of CLs and IOL implants to correct infants vision after unilateral cataract surgery. In addition, a pilot study was begun in March 2002 to evaluate the safety of IOL implantation during infancy and the willingness of parents to randomize their children with a UCC to either IOL implantation or CL correction. RESULTS: In 1997, 89% of the 260 respondents reported that in the previous year they had treated at least one infant with a UCC, but only 4% had implanted an IOL in an infant <7 months old. Silsoft (Bausch & Lomb, Rochester, NY) CL correction was the preferred treatment choice for 84% of the respondents. In 2001, 21% of the 279 respondents had implanted an IOL in an infant. On a scale from 1 to 10 with 1 strongly favoring an IOL implant and 10 strongly favoring a CL, the median score was 7.5. Sixty-one percent of the respondents indicated that they would be willing to randomize children with a UCC to one of these two treatments. The main concerns about IOL implantation were poor predictability of power changes, postoperative complications, inflammation, and technical difficulty of surgery. The main concerns about CL correction were poor compliance, high lens loss rate, high cost, and keratitis. In our pilot study, 30 infants <7 months of age were evaluated at nine clinical centers for a visually significant UCC. Of 24 infants eligible for randomization, the parents of 17 (71%) agreed to randomization. CONCLUSIONS: Although most AAPOS members still favor CL correction after cataract surgery for a UCC, five times as many had implanted an IOL in an infant in 2001 compared with the number in 1997. Parents were almost equally divided in their preference for IOL implant versus CL correction. Given the relative equipoise of AAPOS members regarding these treatments and the willingness of more than two thirds of parents to agree to randomization, it seems likely that a randomized clinical trial comparing these two treatments could indeed be conducted.
RCT Entities:
BACKGROUND: To determine whether a randomized clinical trial, the Infant Aphakia Treatment Study, comparing intraocular lens (IOL) implantation with contact lens (CL) correction for infants with a unilateral congenital cataract (UCC), is feasible by (1) ascertaining whether American Association for Pediatric Ophthalmology and Strabismus (AAPOS) members have equipoise regarding these two treatments and (2) evaluating the willingness of parents to agree to randomization. METHODS: All AAPOS members were surveyed in August 1997 and again in June 2001 regarding their use of CLs and IOL implants to correct infants vision after unilateral cataract surgery. In addition, a pilot study was begun in March 2002 to evaluate the safety of IOL implantation during infancy and the willingness of parents to randomize their children with a UCC to either IOL implantation or CL correction. RESULTS: In 1997, 89% of the 260 respondents reported that in the previous year they had treated at least one infant with a UCC, but only 4% had implanted an IOL in an infant <7 months old. Silsoft (Bausch & Lomb, Rochester, NY) CL correction was the preferred treatment choice for 84% of the respondents. In 2001, 21% of the 279 respondents had implanted an IOL in an infant. On a scale from 1 to 10 with 1 strongly favoring an IOL implant and 10 strongly favoring a CL, the median score was 7.5. Sixty-one percent of the respondents indicated that they would be willing to randomize children with a UCC to one of these two treatments. The main concerns about IOL implantation were poor predictability of power changes, postoperative complications, inflammation, and technical difficulty of surgery. The main concerns about CL correction were poor compliance, high lens loss rate, high cost, and keratitis. In our pilot study, 30 infants <7 months of age were evaluated at nine clinical centers for a visually significant UCC. Of 24 infants eligible for randomization, the parents of 17 (71%) agreed to randomization. CONCLUSIONS: Although most AAPOS members still favor CL correction after cataract surgery for a UCC, five times as many had implanted an IOL in an infant in 2001 compared with the number in 1997. Parents were almost equally divided in their preference for IOL implant versus CL correction. Given the relative equipoise of AAPOS members regarding these treatments and the willingness of more than two thirds of parents to agree to randomization, it seems likely that a randomized clinical trial comparing these two treatments could indeed be conducted.
Authors: Scott R Lambert; Edward G Buckley; Carolyn Drews-Botsch; Lindreth DuBois; E Eugenie Hartmann; Michael J Lynn; David A Plager; M Edward Wilson Journal: Arch Ophthalmol Date: 2010-05-10
Authors: Scott R Lambert; Edward G Buckley; Carolyn Drews-Botsch; Lindreth DuBois; Eugenie Hartmann; Michael J Lynn; David A Plager; M Edward Wilson Journal: Arch Ophthalmol Date: 2010-01