Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliative Glaucoma
Conditions
Keywords
Glaucoma, SLT
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.
Interventions
DEVICESensimed Triggerfish
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed