Clinical trial NCT02253017: Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery
Official title: Assessment Practices Registry in Congenital Cataract Surgery and Infantile
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cataract
Keywords: Therapeutic strategies
Pediatrics
Cataract
Surgery
Intra-ocular lens
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ophthalmology department, Necker hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment practices in Pediatric Cataract Surgery.
timeFrame: 8-10 months,
measure: Assessment practices in Pediatric Cataract Surgery.
timeFrame: 3 years
measure: Assessment practices in Pediatric Cataract Surgery.
timeFrame: 5 years
measure: Assessment practices in Pediatric Cataract Surgery.
timeFrame: 8 years (or 6 months after surgery if the child is carried out after 8 years )
Secondary outcomes:
measure: Type of surgery and surgical procedures
timeFrame: 8-10 months
measure: Type of surgery and surgical procedures
timeFrame: 3 years
measure: Type of surgery and surgical procedures
timeFrame: 5 years
measure: Type of surgery and surgical procedures
timeFrame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
measure: Type of implant
timeFrame: 8-10 months
measure: Type of implant
timeFrame: 3 years
measure: Type of implant
timeFrame: 5 years
measure: Type of implant
timeFrame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
measure: Age at implantation
timeFrame: 8-10 months,
measure: Age at implantation
timeFrame: 3 years,
measure: Age at implantation
timeFrame: 5 years
measure: Age at implantation
timeFrame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
measure: Distance visual acuity
timeFrame: age of 8 years and 6 months after surgery if the child is carried out after the age of 8.
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)
Study officials:
affiliation: Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France
name: Matthieu Robert, MD
role: PRINCIPAL_INVESTIGATOR
References: