Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma

Glaucoma Clinical Trial

— SLT  

Official title:

Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058278
• Other study ID #: DR-002-1213
• Status: Completed
• Phase: N/A
• First received: January 27, 2010
• Last updated: February 26, 2016
• Start date: March 2008
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the SLT.

Description:

The selective laser trabeculoplasty (SLT) is the laser treatment of choice for treating glaucoma. A There is however a controversy regarding the use of drops post-treatment. Indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae "cleaning". Others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suffering from with primary open-angle glaucoma.

• Patients with IOP > 21 mmHg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment.

• Patients > 18 years old, able to consent.

• Patients consenting to the trial.

Exclusion Criteria:

• Patients suffering from chronic glaucoma other than primary open-angle glaucoma

• Patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the SLT

• Patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month.

• Patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae.

• Monophthalmic patients.

• Patients who already underwent a glaucoma treatment to the eye requiring treatment.

• Patients who already underwent a glaucoma treatment using SLT or ALT (Argon laser trabeculoplasty)

• Patients who underwent cataract surgery in the past 3 months.

• Pregnant patients.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Inflammatory Response

Intervention

Procedure:
• Selective Laser trabeculoplasty
The Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days.

Locations

Country	Name	City	State
Canada	Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Canadian Glaucoma Clinical Research Council, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure in the treated eye		1 hour, 7 days, 1.5, 3 and 6 months	Yes
Secondary	Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period)		1 hour, 7 days, 1.5 months, 3 months and 6 months	Yes