IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma
• Intervention / Treatment: Device: Sensimed Triggerfish

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX)
• Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) > 2.5 dB
• No or stable anti-glaucomatous drug therapy since at least 3 months
• Structural and/or functional glaucomatous damage
• Aged more than 18 years, of either sex
• Not more than 6 diopters spherical equivalent on the study eye
• Not more than 2 diopters cylinder equivalent on the study eye
• Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

• Refractory glaucoma
• Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma
• Corneal or conjunctival abnormality precluding contact lens adaptation
• Severe dry eye syndrome
• Patients with allergy to corneal anesthetic
• Patients with contraindications for silicone contact lens wear
• Patients not able to understand the character and individual consequences of the investigation
• Participation in other clinical research within the last 4 weeks
• Any other contra-indication listed in the Triggerfish user manual

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Triggerfish; Device: Sensimed Triggerfish	Device: Sensimed Triggerfish; Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety and tolerability in this patient population	Adverse events and serious adverse events will be collected throughout the duration of the study	1 month

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: Jean-Philippe Nordmann, MD, Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (ESTIMATE): January 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Glaucoma; SLT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: TF-1207