Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery

Cataract Clinical Trial

— EP3C  

Official title:

Assessment Practices Registry in Congenital Cataract Surgery and Infantile

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02253017
• Other study ID #: 2014-06-13
• Status: Withdrawn
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Children operated on for cataract
Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years

Locations

Country	Name	City	State
France	Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,
Primary	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
Primary	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
Primary	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	Type of surgery and surgical procedures		8-10 months
Secondary	Type of surgery and surgical procedures		3 years
Secondary	Type of surgery and surgical procedures		5 years
Secondary	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).
Secondary	Type of implant		8-10 months
Secondary	Type of implant		3 years
Secondary	Type of implant		5 years
Secondary	Type of implant		8 years (or 6 months after surgery if the child is carried out after 8 years).
Secondary	Age at implantation		8-10 months,
Secondary	Age at implantation		3 years,
Secondary	Age at implantation		5 years
Secondary	Age at implantation		8 years (or 6 months after surgery if the child is carried out after 8 years).
Secondary	Distance visual acuity		age of 8 years and 6 months after surgery if the child is carried out after the age of 8.