CataractCHANCT03497481
Neopterin Dosage in the Eye
An observational study of Cataract, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Samples
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2018to 25 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient eligible for non infectious and non inflammatory eye surgery
Who may be able to join
- Age ≥ 18 years-old
- Non inflammatory or non infectious ophthalmic pathology requiring puncture of eye's anterior chamber fluid.
- Minimum of 200 microliter sample
- Immunocompetent subjects
- Signed and dated informed consent
- Samples management in accordance with the pre-analytical conditions specified in the protocol
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- Non-inclusion criteria:
- Age < 18 years-old
- Subjects treated with intraocular corticoids, antibiotics or anti-inflammatory, locally or in systemic injection, prior to inclusion.
Who cannot join
- Subjects who exercised his right of withdrawal
- Study suspended on principal investigator, sponsor or health authorities' demand.
- Deceased subjects
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83200
About this study
Official title: Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.
The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.
Read the detailed description
The study will be explained to subjects who are about to undergo ophthalmologic surgery. They will sign an informed consent and be included in the study. Urine sample will be collected specifically for the study. Eye's anterior chamber fluid will also be collected during the surgery as it is the usual practice (the sample is used for the neopterin dosage instead of being thrown away).
These samples will be centrifuged, frozen in a -80° C freezer. At the end of the study, all the samples will be sent to the central Lab for the neopterin dosage analysis. Results will be communicated to the principal investigator afterward.
- Conditions
- Cataract
- Being tested
- Samples
- Keywords
- eye's anterior chamber fluid, cerebrospinal fluid, inflammatory pathology
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesBiological
Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis
| Study group | Role | What they receive |
|---|---|---|
| Neopterin Dosage | Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis Receives: Biological: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and dosage of neopterin in the eye
HCL will detect and dose the neopterin in the eye's anterior chamber fluid
Measured: 3 month
Secondary outcomes (2)
Neopterin concentration comparison between study values and reference value.
The reference values are standards established by the Neurobiology Lab from Lyon CHU which is the central lab that will performed the neopterin dosages.
Measured: 3 month
False positives identification and elimination.
False positives will be determined by calibration of creatinine dosage in eye and urine samples.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start22 Jun 2018
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Chaker Nefzaoui, doctor, Principal investigator, Centre Hospitalier Intercommunal Toulon La Seyne sur MerAnélia Benarrosh, doctor, Study chair, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497481
- Sponsor's protocol ID
- 2017-CHITS-02
- Other IDs
- 2017-A00183-47
- Acronym
- CHA
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
Kuvbachieva-Benarrosh A, Nefzaoui C, Quadrio I, Remignon CH, Jullian E, Perret-Liaudet A. Neopterin level can be measured by intraocular liquid biopsy. Clin Chem Lab Med. 2022 Oct 14;61(1):e20-e21. doi: 10.1515/cclm-2022-0691. Print 2023 Jan 27. No abstract available.
PubMed 36227583
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.
- ClinicalTrials.gov ID
- NCT03497481
- Acronym / sponsor ID
- CHA / 2017-CHITS-02
- Conditions
- Cataract
- Keywords
- eye's anterior chamber fluid, cerebrospinal fluid, inflammatory pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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 the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.
Detailed description
The study will be explained to subjects who are about to undergo ophthalmologic surgery. They will sign an informed consent and be included in the study. Urine sample will be collected specifically for the study. Eye's anterior chamber fluid will also be collected during the surgery as it is the usual practice (the sample is used for the neopterin dosage instead of being thrown away).
These samples will be centrifuged, frozen in a -80° C freezer. At the end of the study, all the samples will be sent to the central Lab for the neopterin dosage analysis. Results will be communicated to the principal investigator afterward.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neopterin Dosage | – | Biological: SamplesEye's anterior chamber fluid and urines are sampled for posterior neopterin analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient eligible for non infectious and non inflammatory eye surgery
Key inclusion criteria (9 listed)
- Age ≥ 18 years-old
- Non inflammatory or non infectious ophthalmic pathology requiring puncture of eye's anterior chamber fluid.
- Minimum of 200 microliter sample
- Immunocompetent subjects
- Signed and dated informed consent
Key exclusion criteria (3 listed)
- Subjects who exercised his right of withdrawal
- Study suspended on principal investigator, sponsor or health authorities' demand.
- Deceased subjects
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 |
|---|---|---|
| SamplesEye's anterior chamber fluid and urines are sampled for posterior neopterin analysis | Biological | Neopterin Dosage |
Primary outcome
Detection and dosage of neopterin in the eye
Time frame: 3 month
HCL will detect and dose the neopterin in the eye's anterior chamber fluid
2 secondary outcomes
Neopterin concentration comparison between study values and reference value.
Time frame: 3 month
False positives identification and elimination.
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Results publication: PubMed 36227583Kuvbachieva-Benarrosh A, Nefzaoui C, Quadrio I, Remignon CH, Jullian E, Perret-Liaudet A. Neopterin level can be measured by intraocular liquid biopsy. Clin Chem Lab Med. 2022 Oct 14;61(1):e20-e21. doi: 10.1515/cclm-2022-0691. Print 2023 Jan 27. No abstract available.
- Individual participant dataSharing planned: No. no plan
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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.
Chaker Nefzaoui, doctor principal investigator
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Anélia Benarrosh, doctor study chair
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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 Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 9 inclusion and 3 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: finished, as of the sponsor's last update on 26 Oct 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection and dosage of neopterin in the eye (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497481, which also lists 1 linked publication.
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 26 Oct 2022; AzTrials last refreshed its copy on 3 Nov 2026.