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

Sensimed

Status: Completed

Conditions: Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma

Treatments: Device: Sensimed Triggerfish

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767753

TF-1207

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Triggerfish

Experimental group

Description:

Device: Sensimed Triggerfish

Treatment:

Device: Sensimed Triggerfish