Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery

Withdrawn

• Conditions: Cataract
• Interventions: Other: Children operated on for cataract

• Registration Number: NCT02253017
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-10-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children operated on for cataract	Children operated on for cataract	-

Primary Outcome Measures

Name	Time	Method
Assessment practices in Pediatric Cataract Surgery.	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 Outcome Measures

Name	Time	Method
Type of surgery and surgical procedures	8 years (or 6 months after surgery if the child is carried out after 8 years).	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.

Trial Locations

Locations (1)

Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris); 🇫🇷 Paris, France