AquaLase Capsule Wash for Pediatric Eyes

NCT ID: NCT00756327

Last Updated: 2009-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-06-30

Brief Summary

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

Detailed 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.

Conditions

Cataract; Pediatric Cataract

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Bilateral cataract in a child aged 6-15 years old
• Informed consent from the parents/legal guardian.

Exclusion Criteria

• traumatic cataract
• fellow eye - visually not significant cataract
• fellow eye surgery not scheduled within 3-month period after first eye surgery
• dense posterior capsule plaque
• preexisting posterior capsule defect
• subluxated cataract
• high myopia (defined as axial length >24 mm)
• child with multiple disability where it may not be feasible to perform YAG laser capsulotomy in the office, if needed
• Participants with a strong likelihood of non-adherence (difficulties in adhering to follow-up schedule due to geographic distance from clinical center)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Medical University of South Carolina

Principal Investigators

Trivedi Rupalben, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Aravind Haripriya

Madurai, , India

Countries

India

Other Identifiers

MRC-08-001

Identifier Type: -

Identifier Source: org_study_id