CataractTRIGGERFISHNCT02658071
Measurement of Ocular Tensional Fluctuation by Triggerfish Lens Before and After Cataract Surgery in Patients With Exfoliative Glaucoma
An observational study of Cataract and Exfoliative Glaucoma, run by University Hospital, Brest at 1 site in France.
Trial summary
Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and their axons slowly die with visible changes at the optic nerve head (cupping). Without early diagnosis and effective treatment or with delayed treatment decrease of visual acuity or blindness become. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Exfoliative Glaucoma
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2016to 29 Dec 2017
- 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 with exfoliative glaucoma and cataract
Who may be able to join
- Adult
- Exfoliative glaucoma
- Patient who need cataract surgery
- Patient agree with study
Who cannot join
- Monophtalm patient
- Patient with bleb after glaucoma surgery
- Terminal glaucoma
- Herpes
- One year control impossible
Trial locations and contacts
1 site in 1 country.
About this study
Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and their axons slowly die with visible changes at the optic nerve head (cupping). Without early diagnosis and effective treatment or with delayed treatment decrease of visual acuity or blindness become.
In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise. The exfoliation material is found on the surface of the lens capsule with frequent developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP) decrease.
Some recent study have found decreasing ocular volume variation associated to IOP fluctuation in night after cataract surgery in normal pressure glaucoma patients. In our study we want see if it's the same thing in pseudoexfoliation glaucoma patients.
- Conditions
- Cataract, Exfoliative Glaucoma
- Keywords
- exfoliative glaucoma, cataract, ocular pressure
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of ocular tensional fluctuation by Triggerfish lens before and after cataract surgery in patients with exfoliative glaucoma.
Variation of ocular volume
Measured: During 24H00 before and after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start15 Mar 2016
- Primary completion9 Mar 2017
- Study completion29 Dec 2017
Why it stopped: PI left Brest hospital
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 University Hospital, BrestThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Sensimed AG
- Responsible party
- Sponsor
- Investigators
- Catherine COCHARD, Dr, Principal investigator, University Hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658071
- Sponsor's protocol ID
- TRIGGERFISH (RB 15.063)
- Acronym
- TRIGGERFISH
- Status last verified
- Jun 2026
- First submitted
- 14 Jan 2016
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Ocular Tensional Fluctuation by Triggerfish Lens Before and After Cataract Surgery in Patients With Exfoliative Glaucoma
- ClinicalTrials.gov ID
- NCT02658071
- Acronym / sponsor ID
- TRIGGERFISH / TRIGGERFISH (RB 15.063)
- Conditions
- Cataract, Exfoliative Glaucoma
- Keywords
- exfoliative glaucoma, cataract, ocular pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left Brest hospital
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Sensimed AG
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 18 Jan 2016 (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.
Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and their axons slowly die with visible changes at the optic nerve head (cupping). Without early diagnosis and effective treatment or with delayed treatment decrease of visual acuity or blindness become.
In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise. The exfoliation material is found on the surface of the lens capsule with frequent developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP) decrease.
Some recent study have found decreasing ocular volume variation associated to IOP fluctuation in night after cataract surgery in normal pressure glaucoma patients. In our study we want see if it's the same thing in pseudoexfoliation glaucoma patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with exfoliative glaucoma and cataract
Key inclusion criteria (4 listed)
- Adult
- Exfoliative glaucoma
- Patient who need cataract surgery
- Patient agree with study
Key exclusion criteria (5 listed)
- Monophtalm patient
- Patient with bleb after glaucoma surgery
- Terminal glaucoma
- Herpes
- One year control impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of ocular tensional fluctuation by Triggerfish lens before and after cataract surgery in patients with exfoliative glaucoma.
Time frame: During 24H00 before and after cataract surgery
Variation of ocular volume
Results and safety
The study was stopped early (reason given: PI left Brest hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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.
Catherine COCHARD, Dr principal investigator
University Hospital of Brest
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 and Exfoliative Glaucoma, run by University Hospital, Brest 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Jun 2026. 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 stopped early (reason given: PI left Brest hospital). Results are not available in the source record.
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?
Measurement of ocular tensional fluctuation by Triggerfish lens before and after cataract surgery in patients with exfoliative glaucoma. (time frame: During 24H00 before and after cataract surgery). 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 8 Jun 2026.