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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767753
• Other study ID #: TF-1207
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: November 16, 2015
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2015
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Pigmentary Glaucoma
• Primary Open Angle Glaucoma
• Pseudoexfoliative Glaucoma

Intervention

Device:
• Sensimed Triggerfish
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Locations

Country	Name	City	State
France	Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess IOP patterns of POAG patients during office hours	Overall variability; Diurnal and nocturnal IOP patterns; Number of peaks in the study population before and after SLT	1 month	No
Secondary	Safety and tolerability in this patient population	Adverse events and serious adverse events will be collected throughout the duration of the study	1 month	Yes