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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01767753
Other study ID # TF-1207
Secondary ID
Status Completed
Phase N/A
First received January 10, 2013
Last updated November 16, 2015
Start date November 2012
Est. completion date July 2014

Study information

Verified date November 2015
Source Sensimed AG
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.

The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.


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Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Device:
Sensimed Triggerfish
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Locations

Country Name City State
France Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts Paris

Sponsors (1)

Lead Sponsor Collaborator
Sensimed AG

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT. Wake-to-Sleep slopes
Overall variability
Diurnal and nocturnal IOP patterns
Number of peaks
1 months No
Secondary To assess IOP patterns of POAG patients during office hours Overall variability
Diurnal and nocturnal IOP patterns
Number of peaks in the study population before and after SLT
1 month No
Secondary Safety and tolerability in this patient population Adverse events and serious adverse events will be collected throughout the duration of the study 1 month Yes
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