CataractEP3CNCT02253017
Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery
An observational study of Cataract, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this observational study is to assess the therapeutic strategies in the treatment of pediatric cataracts. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Cataract
- What is being tested?
- Children operated on for cataract
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: ophthalmology department, Necker hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)
Paris, 75015
About this study
Official title: Assessment Practices Registry in Congenital Cataract Surgery and Infantile
The purpose of this observational study is to assess the therapeutic strategies in the treatment of pediatric cataracts.
Read the 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.
- Conditions
- Cataract
- Being tested
- Children operated on for cataract
- Keywords
- Therapeutic strategies, Pediatrics, Cataract, Surgery, Intra-ocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children operated on for cataractOther
Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years
| Study group | Role | What they receive |
|---|---|---|
| Children operated on for cataract | Not described Receives: Other: Children operated on for cataract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 years (or 6 months after surgery if the child is carried out after 8 years )
Secondary outcomes (13)
Type of surgery and surgical procedures
Measured: 8-10 months
Type of surgery and surgical procedures
Measured: 3 years
Type of surgery and surgical procedures
Measured: 5 years
Type of surgery and surgical procedures
8 years (or 6 months after surgery if the child is carried out after 8 years).
Measured: 8 years (or 6 months after surgery if the child is carried out after 8 years).
Type of implant
Measured: 8-10 months
Type of implant
Measured: 3 years
Type of implant
Measured: 5 years
Type of implant
Measured: 8 years (or 6 months after surgery if the child is carried out after 8 years).
Age at implantation
Measured: 8-10 months,
Age at implantation
Measured: 3 years,
Age at implantation
Measured: 5 years
Age at implantation
Measured: 8 years (or 6 months after surgery if the child is carried out after 8 years).
Distance visual acuity
Measured: age of 8 years and 6 months after surgery if the child is carried out after the age of 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014 (estimated)
- Primary completionDec 2015 (estimated)
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Matthieu Robert, MD, Principal investigator, Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253017
- Sponsor's protocol ID
- 2014-06-13
- Acronym
- EP3C
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Practices Registry in Congenital Cataract Surgery and Infantile
- ClinicalTrials.gov ID
- NCT02253017
- Acronym / sponsor ID
- EP3C / 2014-06-13
- Conditions
- Cataract
- Keywords
- Therapeutic strategies, Pediatrics, Cataract, Surgery, Intra-ocular lens
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2014 (estimated)
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children operated on for cataract | – | Other: Children operated on for cataract |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ophthalmology department, Necker hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Children operated on for cataractCompilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years | Other | Children operated on for cataract |
Primary outcome
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
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
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
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
13 secondary outcomes
Type of surgery and surgical procedures
Time frame: 8-10 months
Type of surgery and surgical procedures
Time frame: 3 years
Type of surgery and surgical procedures
Time frame: 5 years
Type of surgery and surgical procedures
Time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
Type of implant
Time frame: 8-10 months
Type of implant
Time frame: 3 years
Type of implant
Time frame: 5 years
Type of implant
Time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
Age at implantation
Time frame: 8-10 months,
Age at implantation
Time frame: 3 years,
Age at implantation
Time frame: 5 years
Age at implantation
Time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Robert, MD principal investigator
Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment practices in Pediatric Cataract Surgery. (time frame: 8-10 months,). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.