NCT00756327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

1.8 years

First QC Date

September 18, 2008

Last Update Submit

August 14, 2009

Conditions

CataractPediatric Cataract

Keywords

pediatric eyesbilateral cataractIOL implantationAqualase capsule washposterior capsule opacification

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Haripriya

Madurai, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Trivedi Rupalben, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 22, 2008

Study Start

August 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

IN(1)