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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03289806
Other study ID # DELAZZER 2016
Secondary ID
Status Recruiting
Phase N/A
First received September 19, 2017
Last updated September 19, 2017
Start date January 12, 2016
Est. completion date January 2018

Study information

Verified date September 2017
Source Centre Hospitalier Universitaire Dijon
Contact Alain BRON
Phone 03 80 29 37 56
Email alain.bron@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing trabulectomy or deep sclerectomy

- Patients informed about the study

Exclusion Criteria:

- Patients who refuse to take part in the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Samples of fibroblasts from Tenon's capsule


Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) At baseline
Primary Test migration ability by video microscopy At baseline
Primary Test proliferation with immunohistochemistry (Ki67 staining) At baseline
Primary Analysis of cell cycle in flow cytometry At baseline