Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measurement of Ocular Tensional Fluctuation by Triggerfish Lens Before and After Cataract Surgery in Patients With Exfoliative Glaucoma (TRIGGERFISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658071
Recruitment Status : Unknown
Verified June 2017 by University Hospital, Brest.
Recruitment status was:  Recruiting
First Posted : January 18, 2016
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Sensimed AG
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Cataract Exfoliative Glaucoma

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : March 15, 2016
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with exfoliative glaucoma and cataract
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Monophtalm patient
  • Patient with bleb after glaucoma surgery
  • Terminal glaucoma
  • Herpes
  • One year control impossible
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658071


Contacts
Layout table for location contacts
Contact: Catherine COCHARD, Dr catherine.cochardmarianowski@gmail.fr

Locations
Layout table for location information
France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Catherine Cochard       catherine.cochardmarianowski@gmail.fr   
Sponsors and Collaborators
University Hospital, Brest
Sensimed AG
Investigators
Layout table for investigator information
Principal Investigator: Catherine COCHARD, Dr University Hospital of Brest
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02658071    
Other Study ID Numbers: TRIGGERFISH (RB 15.063)
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Brest:
exfoliative glaucoma
cataract
ocular pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases