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

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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
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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
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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
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Outcome Measures
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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
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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
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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
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Contact: Catherine COCHARD, Dr catherine.cochardmarianowski@gmail.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Catherine Cochard       catherine.cochardmarianowski@gmail.fr   
Sponsors and Collaborators
University Hospital, Brest
Sensimed AG
Investigators
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Principal Investigator: Catherine COCHARD, Dr University Hospital of Brest
More Information
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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:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases