Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery

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

Detailed Description
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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.

Official Title
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Assessment Practices Registry in Congenital Cataract Surgery and Infantile

Conditions
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Cataract

Intervention / Treatment
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* Other: Children operated on for cataract


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children operated on for cataract<br> | Other: Children operated on for cataract<br>* Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic strategies, Pediatrics, Cataract, Surgery, Intra-ocular lens