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

Not Applicable

Completed

• Conditions: Pigmentary Glaucoma; Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma
• Interventions: Device: Sensimed Triggerfish

• Registration Number: NCT01767753
• Lead Sponsor: Sensimed AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triggerfish	Sensimed Triggerfish	Device: Sensimed Triggerfish

Primary Outcome Measures

Name	Time	Method
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.	1 months	* Wake-to-Sleep slopes; * Overall variability; * Diurnal and nocturnal IOP patterns; * Number of peaks

Secondary Outcome Measures

Name	Time	Method
To assess IOP patterns of POAG patients during office hours	1 month	Overall variability; * Diurnal and nocturnal IOP patterns; * Number of peaks in the study population before and after SLT
Safety and tolerability in this patient population	1 month	Adverse events and serious adverse events will be collected throughout the duration of the study

Trial Locations

Locations (1)

Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts; 🇫🇷 Paris, France