NCT02253017

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 26, 2014

Last Update Submit

November 17, 2025

Conditions

Cataract

Keywords

Therapeutic strategiesPediatricsCataractSurgeryIntra-ocular lens

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (13)

  • 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).

  • Type of implant

    8-10 months

  • +8 more secondary outcomes

Study Arms (1)

Children operated on for cataract

Other: Children operated on for cataract

Interventions

Children operated on for cataractOTHER

Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years

Children operated on for cataract

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

ophthalmology department, Necker hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)

Paris, 75015, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Matthieu Robert, MD

    Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 1, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 20, 2025

Record last verified: 2025-09

Locations

FR(1)