Assessment Practices Registry in Congenital Cataract Surgery and Infantile
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Assessment practices in Pediatric Cataract Surgery.
Study Overview
Brief Summary
The purpose of this observational study is to assess the therapeutic strategies in the treatment of pediatric cataracts.
Detailed Description
Technical progress and recently described potential issues have recently challenged the surgical treatment of pediatric cataracts. Many questions remain unsolved: primary vs secondary implantation, nature of the implant used. The aim of this study is to establish a systematic prospective register of all cataracts operated on in a tertiary pediatric centre in order to help answering these questions.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Child cataract surgery from 1 September 2014 in the Department of Ophthalmology, University Hospital Necker-Enfants Malades
- •Children aged between 0 and 17 years
- •Child with unilateral or bilateral cataract
Exclusion Criteria
- •Child with bilateral cataract, one eye having previously been operated in another center.
- •Children whose parents have notified the doctor their refusal of data collection
Outcomes
Primary Outcomes
Assessment practices in Pediatric Cataract Surgery.
Time Frame: 8 years (or 6 months after surgery if the child is carried out after 8 years )
* Rating of efficacy of surgery depending on the implementation or not of a primary location * Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal) * Evaluation of effectiveness of surgery based on age (\<8 weeks of age for unilateral surgery and \<11 weeks of life for bilateral surgeries) * To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary
Secondary Outcomes
- Type of surgery and surgical procedures(8 years (or 6 months after surgery if the child is carried out after 8 years).)
- Type of implant(8 years (or 6 months after surgery if the child is carried out after 8 years).)
- Age at implantation(8 years (or 6 months after surgery if the child is carried out after 8 years).)
- Distance visual acuity(age of 8 years and 6 months after surgery if the child is carried out after the age of 8.)