Clinical trial NCT01767753: IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Pigmentary Glaucoma
Pseudoexfoliative Glaucoma
Keywords: Glaucoma
SLT
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 months
Secondary outcomes:
measure: To assess IOP patterns of POAG patients during office hours
timeFrame: 1 month
measure: Safety and tolerability in this patient population
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts
Study officials:
affiliation: Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts
name: Jean-Philippe Nordmann, MD
role: PRINCIPAL_INVESTIGATOR
References: