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Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery (EP3C)

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ClinicalTrials.gov Identifier: NCT02253017
Recruitment Status : Recruiting
First Posted : October 1, 2014
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Children Operated on for Cataract in Ophthalmology at Necker Hospital. 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment Practices Registry in Congenital Cataract Surgery and Infantile
Study Start Date : September 2014
Estimated Primary Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort 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




Primary Outcome Measures :
  1. Assessment practices in Pediatric Cataract Surgery. [ Time Frame: 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

  2. Assessment practices in Pediatric Cataract Surgery. [ Time Frame: 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

  3. Assessment practices in Pediatric Cataract Surgery. [ Time Frame: 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

  4. Assessment practices in Pediatric Cataract Surgery. [ Time Frame: 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 :
  1. Type of surgery and surgical procedures [ Time Frame: 8-10 months ]
  2. Type of surgery and surgical procedures [ Time Frame: 3 years ]
  3. Type of surgery and surgical procedures [ Time Frame: 5 years ]
  4. Type of surgery and surgical procedures [ Time Frame: 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).

  5. Type of implant [ Time Frame: 8-10 months ]
  6. Type of implant [ Time Frame: 3 years ]
  7. Type of implant [ Time Frame: 5 years ]
  8. Type of implant [ Time Frame: 8 years (or 6 months after surgery if the child is carried out after 8 years). ]
  9. Age at implantation [ Time Frame: 8-10 months, ]
  10. Age at implantation [ Time Frame: 3 years, ]
  11. Age at implantation [ Time Frame: 5 years ]
  12. Age at implantation [ Time Frame: 8 years (or 6 months after surgery if the child is carried out after 8 years). ]
  13. Distance visual acuity [ Time Frame: age of 8 years and 6 months after surgery if the child is carried out after the age of 8. ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ophthalmology department, Necker hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253017


Contacts
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Contact: Matthieu Robert, MD +33 1 44 49 53 62 matthieu.robert@nck.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
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France
Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris) Recruiting
Paris, France, 75015
Contact: Matthieu Robert, MD    +33 1 44 49 53 62    matthieu.robert@nck.aphp.fr   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Matthieu Robert, MD Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02253017     History of Changes
Other Study ID Numbers: 2014-06-13
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Therapeutic strategies
Pediatrics
Cataract
Surgery
Intra-ocular lens

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases