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Sponsors and Collaborators: |
Medical University of South Carolina Alcon Research |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00756327 |
To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in pediatric eyes.
Condition |
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Cataract Pediatric Cataract |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | AquaLase Capsule Wash for Pediatric Eyes |
Estimated Enrollment: | 20 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 6 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Children with bilateral cataract undergoing surgery for cataract aspiration and IOL implantation. Bilateral cataract in a child aged 6-15 years old.
Inclusion Criteria:
Exclusion Criteria:
Contact: Rupalben Trivedi, MD | 843-792-6301 | trivedi@musc.edu |
Contact: Lisa Graves, BA | 843-792-3948 | gravesl@musc.edu |
India | |
Aravind Haripriya | Recruiting |
Madurai, India | |
Contact: Rupalben Trivedi, MD 843-792-6301 |
Principal Investigator: | Trivedi Rupalben, MD | Assistant Professor |
Responsible Party: | Medical University of South Carolina ( Rupalben Trivedi, MD ) |
Study ID Numbers: | MRC-08-001 |
Study First Received: | September 18, 2008 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00756327 History of Changes |
Health Authority: | United States: Institutional Review Board |
pediatric eyes bilateral cataract IOL implantation Aqualase capsule wash posterior capsule opacification |
Eye Diseases Cataract Lens Diseases |
Eye Diseases Cataract Lens Diseases |