NCT02658071

Brief 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. 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.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

January 14, 2016

Last Update Submit

June 12, 2017

Conditions

CataractExfoliative Glaucoma

Keywords

exfoliative glaucomacataractocular pressure

Outcome Measures

Primary Outcomes (1)

  • Measurement of ocular tensional fluctuation by Triggerfish lens before and after cataract surgery in patients with exfoliative glaucoma.

    Variation of ocular volume

    During 24H00 before and after cataract surgery

Eligibility Criteria

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

Patient with exfoliative glaucoma and cataract

You may qualify if:

  • Adult
  • Exfoliative glaucoma
  • Patient who need cataract surgery
  • Patient agree with study

You may not qualify if:

  • Monophtalm patient
  • Patient with bleb after glaucoma surgery
  • Terminal glaucoma
  • Herpes
  • One year control impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Catherine COCHARD, Dr

    University Hospital of Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine COCHARD, Dr

CONTACT

catherine.cochardmarianowski@gmail.fr

Study Design

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

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

March 15, 2016

Primary Completion

September 15, 2018

Study Completion

September 15, 2018

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

FR(1)