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

Cataract Clinical Trial

— TRIGGERFISH  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02658071
• Other study ID #: TRIGGERFISH (RB 15.063)
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2016
• Last updated: June 12, 2017
• Start date: March 15, 2016
• Est. completion date: September 15, 2018

Study information

• Verified date: June 2017
• Source: University Hospital, Brest
• Contact: Catherine COCHARD, Dr
• Email: catherine.cochardmarianowski[@]gmail.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Exfoliative Glaucoma
• Glaucoma

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Sensimed AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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