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

NCT ID: NCT01767753

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma Pigmentary Glaucoma Pseudoexfoliative Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Triggerfish

Device: Sensimed Triggerfish

Group Type EXPERIMENTAL

Sensimed Triggerfish

Intervention Type DEVICE

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

Interventions

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Sensimed Triggerfish

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sensimed AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe Nordmann, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Locations

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Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts

Paris, , France

Site Status

Countries

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France

Other Identifiers

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TF-1207

Identifier Type: -

Identifier Source: org_study_id