NCT03289806

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 19, 2017

Last Update Submit

September 19, 2017

Conditions

TrabulectomyDeep Sclerectomy

Outcome Measures

Primary Outcomes (4)

  • Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)

    At baseline

  • Test migration ability by video microscopy

    At baseline

  • Test proliferation with immunohistochemistry (Ki67 staining)

    At baseline

  • Analysis of cell cycle in flow cytometry

    At baseline

Study Arms (2)

Cases

Glaucoma surgery

Procedure: Samples of fibroblasts from Tenon's capsule

Controls

Strabismus surgery

Procedure: Samples of fibroblasts from Tenon's capsule

Interventions

Samples of fibroblasts from Tenon's capsulePROCEDURE
CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery for glaucoma or strabismus

You may qualify if:

  • Patients undergoing trabulectomy or deep sclerectomy
  • Patients informed about the study

You may not qualify if:

  • \- Patients who refuse to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

fibroblasts of Tenon's capsule (surgical waste)

Central Study Contacts

Alain BRON

CONTACT

03 80 29 37 56alain.bron@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 21, 2017

Study Start

January 12, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

FR(1)