TrabulectomyDHANCT03289806
Effects of DHA on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery
An observational study of Trabulectomy and Deep Sclerectomy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trabulectomy, Deep Sclerectomy
- What is being tested?
- Samples of fibroblasts from Tenon's capsule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2016to Jan 2018
- 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: Patients undergoing surgery for glaucoma or strabismus
Who may be able to join
- Patients undergoing trabulectomy or deep sclerectomy
- Patients informed about the study
Who cannot join
- Patients who refuse to take part in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon
Alain BRON, 03 80 29 37 56 ext. +33, alain.bron@chu-dijon.fr
About this study
Official title: Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery
Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.
- Conditions
- Trabulectomy, Deep Sclerectomy
- Being tested
- Samples of fibroblasts from Tenon's capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples of fibroblasts from Tenon's capsuleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cases | Glaucoma surgery Receives: Procedure: Samples of fibroblasts from Tenon's capsule | |
| Controls | Strabismus surgery Receives: Procedure: Samples of fibroblasts from Tenon's capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)
Measured: At baseline
Test migration ability by video microscopy
Measured: At baseline
Test proliferation with immunohistochemistry (Ki67 staining)
Measured: At baseline
Analysis of cell cycle in flow cytometry
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start12 Jan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrabulectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289806
- Sponsor's protocol ID
- DELAZZER 2016
- Acronym
- DHA
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 21 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT03289806
- Acronym / sponsor ID
- DHA / DELAZZER 2016
- Conditions
- Trabulectomy, Deep Sclerectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Sep 2017 (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.
Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Samples of fibroblasts from Tenon's capsuleGlaucoma surgery |
| Controls | – | Procedure: Samples of fibroblasts from Tenon's capsuleStrabismus surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for glaucoma or strabismus
Key inclusion criteria (2 listed)
- Patients undergoing trabulectomy or deep sclerectomy
- Patients informed about the study
Key exclusion criteria (1 listed)
- Patients who refuse to take part in the study
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 |
|---|---|---|
| Samples of fibroblasts from Tenon's capsule | Procedure or surgery | Cases, Controls |
Primary outcome
Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)
Time frame: At baseline
Test migration ability by video microscopy
Time frame: At baseline
Test proliferation with immunohistochemistry (Ki67 staining)
Time frame: At baseline
Analysis of cell cycle in flow cytometry
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
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.
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 Trabulectomy and Deep Sclerectomy, run by Centre Hospitalier Universitaire Dijon 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain BRON (03 80 29 37 56 ext. +33, alain.bron@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) (time frame: At baseline). 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 21 Sep 2017.