Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial
2 other identifiers
interventional
61
0 countries
N/A
Brief Summary
This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 29, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedJuly 8, 2015
July 1, 2015
2 years
June 29, 2015
July 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Posterior capsule opacification requiring surgery
opacification of visual axis
12 months postoperatively
Secondary Outcomes (3)
inflammation on slitlamp examination
12 months postoperatively
inflammation on slitlamp examination
12 months postoperatively
intraocular pressure in mmHg
12 months postoperatively
Study Arms (2)
In the bag IOL
ACTIVE COMPARATORCataract surgery with IOL implantation in the capsular bag
Optic Capture of IOL
ACTIVE COMPARATORintraocular lens implantation in the capsular bag with posterior optic capture
Interventions
intraocular lens implantation in the capsular bag or optic capture
Eligibility Criteria
You may qualify if:
- uncomplicated cataract,
- unilateral or bilateral cataract,
- corneal diameter \>9.0mmHg
You may not qualify if:
- pre-existing glaucoma,
- uveitis,
- ocular comorbidity,
- microphthalmos,
- microcornea,
- parents not consenting to participate in study,
- traumatic cataract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
abhay vasavada, MS,FRCS
Iladevi Cataract & IOL Research Centre, Ahmedabad, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
June 29, 2015
First Posted
July 8, 2015
Study Start
April 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 8, 2015
Record last verified: 2015-07