AquaLase Capsule Wash for Pediatric Eyes

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00756327
First received: September 18, 2008
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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


Condition
Cataract
Pediatric Cataract

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: AquaLase Capsule Wash for Pediatric Eyes

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Enrollment: 20
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children with bilateral cataract undergoing surgery for cataract aspiration and IOL implantation. Bilateral cataract in a child aged 6-15 years old.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756327

Locations
India
Aravind Haripriya
Madurai, India
Sponsors and Collaborators
Medical University of South Carolina
Alcon Research
Investigators
Principal Investigator: Trivedi Rupalben, MD Assistant Professor
  More Information

No publications provided

Responsible Party: Rupalben Trivedi, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00756327     History of Changes
Other Study ID Numbers: MRC-08-001
Study First Received: September 18, 2008
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
pediatric eyes
bilateral cataract
IOL implantation
Aqualase capsule wash
posterior capsule opacification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2014