Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery (EP3C)

Assessment Practices Registry in Congenital Cataract Surgery and Infantile

The purpose of this observational study is to assess the therapeutic strategies in the treatment of pediatric cataracts.

Study Overview

• Status: Withdrawn
• Conditions: Cataract
• Intervention / Treatment: Other: Children operated on for cataract

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ophthalmology department, Necker hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children operated on for cataract	Other: Children operated on for cataract; Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment practices in Pediatric Cataract Surgery.	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	8-10 months,
Assessment practices in Pediatric Cataract Surgery.	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	3 years
Assessment practices in Pediatric Cataract Surgery.	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	5 years
Assessment practices in Pediatric Cataract Surgery.	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	8 years (or 6 months after surgery if the child is carried out after 8 years )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of surgery and surgical procedures		8-10 months
Type of surgery and surgical procedures		3 years
Type of surgery and surgical procedures		5 years
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		8-10 months
Type of implant		3 years
Type of implant		5 years
Type of implant		8 years (or 6 months after surgery if the child is carried out after 8 years).
Age at implantation		8-10 months,
Age at implantation		3 years,
Age at implantation		5 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.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Matthieu Robert, MD, Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2014
• Primary Completion (Estimated): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimated): October 1, 2014

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; Pediatrics; Cataract; Therapeutic strategies; Intra-ocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2014-06-13