Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery (EP3C)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment practices in Pediatric Cataract Surgery.
Time Frame: 8-10 months,
  • 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.
Time Frame: 3 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
3 years
Assessment practices in Pediatric Cataract Surgery.
Time Frame: 5 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
5 years
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
8 years (or 6 months after surgery if the child is carried out after 8 years )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Type of surgery and surgical procedures
Time Frame: 8-10 months
8-10 months
Type of surgery and surgical procedures
Time Frame: 3 years
3 years
Type of surgery and surgical procedures
Time Frame: 5 years
5 years
Type of surgery and surgical procedures
Time Frame: 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).
8 years (or 6 months after surgery if the child is carried out after 8 years).
Type of implant
Time Frame: 8-10 months
8-10 months
Type of implant
Time Frame: 3 years
3 years
Type of implant
Time Frame: 5 years
5 years
Type of implant
Time Frame: 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).
Age at implantation
Time Frame: 8-10 months,
8-10 months,
Age at implantation
Time Frame: 3 years,
3 years,
Age at implantation
Time Frame: 5 years
5 years
Age at implantation
Time Frame: 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).
Distance visual acuity
Time Frame: age of 8 years and 6 months after surgery if the child is carried out after the age of 8.
age of 8 years and 6 months after surgery if the child is carried out after the age of 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
URC-CIC Paris Descartes Necker Cochin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthieu Robert, MD, Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-06-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings