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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

Tracking Information
First Submitted Date January 14, 2016
First Posted Date January 18, 2016
Last Update Posted Date June 14, 2017
Actual Study Start Date March 15, 2016
Estimated Primary Completion Date September 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement of Ocular Tensional Fluctuation by Triggerfish Lens Before and After Cataract Surgery in Patients With Exfoliative Glaucoma
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with exfoliative glaucoma and cataract
Condition
  • Cataract
  • Exfoliative Glaucoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 15, 2016)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 15, 2018
Estimated Primary Completion Date September 15, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02658071
Other Study ID Numbers TRIGGERFISH (RB 15.063)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Sensimed AG
Investigators
Principal Investigator: Catherine COCHARD, Dr University Hospital of Brest
PRS Account University Hospital, Brest
Verification Date June 2017