EP3C: Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02253017

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment Practices Registry in Congenital Cataract Surgery and Infantile

Anticipated Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Assessment practices in Pediatric Cataract Surgery. [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
Assessment practices in Pediatric Cataract Surgery. [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
Assessment practices in Pediatric Cataract Surgery. [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
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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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