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

NCT01767753 | Completed

• 1 other identifier: TF-1207
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma

Keywords

Glaucoma; SLT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To assess IOP patterns of POAG patients during office hours

  1 month

• Safety and tolerability in this patient population

  1 month

Study Arms (1)

Triggerfish

EXPERIMENTAL

Device: Sensimed Triggerfish

Device: Sensimed Triggerfish

Interventions

Sensimed Triggerfish DEVICE

Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Triggerfish

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Paris, 75012, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Jean-Philippe Nordmann, MD

  Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

FR (1)