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Researchers to compare contact lenses, IOL implantation in infants
The Infant Aphakia Treatment Study will try to determine which treatment is better after congenital cataract surgery.
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A randomized, multicenter study seeks to determine the best treatment after unilateral cataract surgery during infancy — contact lenses or IOLs — in patients as young as 1 month of age.
Scott R. Lambert, MD, and colleagues are continuing enrollment for the Infant Aphakia Treatment Study to evaluate if there is a difference in treatment with contact lenses and IOLs in infants with congenital cataract. Dr. Lambert said the researchers hope to complete enrollment for the study by September 2008, with a report on the first phase of the study a year after that.
“Aphakia is often found at birth, but surgery is delayed until [infants] are a month of age because there are issues in doing it at such a young age and because of the increasing number of potential issues with anesthesia in a young child.” Dr. Lambert said in a telephone interview with Ocular Surgery News. “There is no evidence that they do better before 1 month of age in terms of their visual outcomes.”
Dr. Lambert said that the standard practice has been for most surgeons to place IOLs in children who are at least 1 year of age.
“That’s done quite commonly now, but there’s still a lot of controversy about using IOLs in very young babies, particularly babies who are 4 to 6 weeks of age,” he said.
Enrollment
 Scott R. Lambert |
To be enrolled in the study, which is funded by the National Eye Institute, infants must have a unilateral visually significant congenital cataract after a 36 gestational week or longer pregnancy. Infants with a history of glaucoma, uveitis, retinal or optic nerve disease, or other ocular disease are excluded.
To date, investigators at 12 U.S. centers have enrolled 91 of 115 eligible patients, and they anticipate enrolling a total of 114 patients between the ages of 1 month and 7 months.
So far, 40 patients between 4 weeks and 6 weeks of age, 25 patients between 7 weeks and 3 months of age, and 26 patients between 4 and 6 months of age have been enrolled, Dr. Lambert said.
“We don’t allow the patients to have the surgery before 4 weeks of age in the study because of the increased risk of complications developing in the eyes of these very young babies,” he said.
The study
Each child is randomly assigned to one of two treatments — cataract removal with IOL implantation and glasses or cataract removal and a contact lens. The main study outcomes include visual acuity, occurrence of complications and parenting stress.
“When we first proposed the study, there was a concern that the parents would not be willing to [have their children] randomized into this study,” Dr. Lambert said. “In fact, we’ve had a good response from parents, with 79% of [them who have] children who are eligible agreeing to be in the study, which is a much higher percentage than we had hoped for.”
Parents are required to bring their children in for examinations every 3 months after surgery.
“More than 95% [of follow-up visits] have been completed, so we’ve had pretty good retention,” he said.
Visual acuity in each patient will be measured starting at age 1 year. The test uses a puppet stage to engage the child and minimize distractions while the examiner determines if the child is looking at stripes on Teller Acuity Cards.
“We hold up cards with stripes on one side and see which side they look at. That’s called forced choice preferential looking,” Dr. Lambert said.
The examiner will initially use cards with large stripes before changing to cards with smaller stripes. Eventually, the stripes will be too small for the child to see and they will blend into the background. The tester will be watching the eyes and face of the child to determine when he can no longer see the stripes.
Dr. Lambert said the researchers have recently received confirmation of additional funding to test the visual acuity of these children at age 4.5 years. That follow-up will assess optotype acuity, stereopsis and ocular motility. They also plan to perform tonometry, contact biometry and specular microscopy when these children are 5 years of age. In addition, a Child Behavior Checklist will test behavioral adjustment.
Quality of life
Researchers will also examine quality-of-life issues. For example, parenting stress will be assessed shortly after surgery and at 1 year of age using a questionnaire.
“One of the things we were interested in knowing was whether one treatment was more stressful for the parents than the other,” Dr. Lambert said. “[The Parenting Stress Index] looks at how much stress is placed on parents during treatment. It isn’t specific for looking at eye diseases, but at how having a sick child might cause stress for parents. We have added questions to it, though, to look specifically at whether this eye treatment has an effect on the child.”
Dr. Lambert said he believes the study will provide guidance to ophthalmologists about which treatment is best for children with congenital cataracts.
“Right now, we don’t know the answer to that. Certainly, the treatment that is the standard of care right now is to treat them with contact lenses,” he said. “[Yet] there are problems associated with wearing contact lenses in babies. They frequently lose them, and many object to having them put in and taken out. … Some parents really struggle to put them in and take them out.”
For more information:
- Scott R. Lambert, MD, can be reached Emory University Eye Center, 1365 Clifton Road, Atlanta, GA 30322; 404-778-5121; fax: 404-778-5203; e-mail: slamber@emory.edu.
- John Misiano is an OSN Staff Writer who covers all aspects of ophthalmology.