AquaLase Capsule Wash for Pediatric Eyes

Status Completed

Clinical Trial Summary

To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in pediatric eyes.

Clinical Trial Description

Dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years. Intraocular lens (IOL) implantation has been universally accepted as the standard of care for most children undergoing cataract surgery beyond infancy. Despite advances in cataract surgery in children, PCO remained a significant complication following pediatric cataract surgery. In addition to being visually disturbing, it also induces amblyopia in children and if not treated at the earliest, irreversible visual changes may occur. The younger the child, the more acute is the problem: PCO occurs faster and the effect of amblyopia is more pronounced.

To prevent opacification of the visual axis after cataract surgery, primary posterior capsulectomy and vitrectomy are routinely needed while managing pediatric cataract. This surgical step is not routinely used in adult cataract surgery, where we prefer an intact posterior capsule. Researchers are constantly trying to find a way to avoid the need for invasive procedures like posterior capsulectomy and vitrectomy for pediatric eyes. Use of AquaLase technology has shown some capability in cleaning the capsular bag during cataract surgery. Observations of this include anecdotal observation from users. AquaLase for cataract removal with the Infiniti Vision System has been used since 2003, is registered, and the FDA clearance is 510(k) number K980292. AquaLase uses pulses of warmed balanced salt solution to gently emulsify and facilitate aspiration of cataracts. The device under evaluation falls under the same FDA clearance. The unique aspect is the application tip which is intended to allow more thorough capsular bag cleaning or removal of more residual lens material than is currently being achieved. The energy source, controls, and materials are all identical to the currently marketed product. The difference is in the geometry of the distal most end of the application tip. ;

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00756327
Study type	Observational
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	N/A
Start date	August 2007
Completion date	June 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.