Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation
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ClinicalTrials.gov Identifier: NCT00366613
Recruitment Status :
(We wish to wait until there is more data available using this substance.)
This study involves using both a device that seals the capsular bag (where the lens is located) allowing safer irrigation of the capsular bag and sodium chloride to irrigate the capsular bag during cataract surgery on children. The purpose of this study is to determine if the use of the device, Perfect Capsule, along with sodium chloride reduces the development of posterior capsule opacification (PCO), a possible complication of cataract surgery. PCO is the clouding of the rear portion of the natural membrane or capsule that holds the artificial lens. It requires additional procedures to correct the problem. Sodium chloride is not usually used during cataract surgery. It will be used to irrigate the capsular bag and remove any residual cells that contribute to the development of PCO. Perfect Capsule will prevent the sodium chloride from touching other parts of the eye. The goal of this study is to determine if irrigation with sodium chloride will lower the incidence of PCO after cataract surgery.
Condition or disease
Procedure: Cataract surgery with Perfect Capsule and Sodium Chloride
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Ages Eligible for Study:
4 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
4 - 18 years of age
Informed consent from the parents/legal guardian.
fellow eye - visually not significant cataract
fellow eye surgery not planned during the study enrollment period