Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
This study is ongoing, but not recruiting participants.
Sponsor:
Laval University
Collaborators:
Canadian Glaucoma Clinical Research Council
Pfizer
Information provided by (Responsible Party):
Béatrice Des Marchais, Laval University
ClinicalTrials.gov Identifier:
NCT01058278
First received: January 27, 2010
Last updated: July 3, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma Inflammatory Response |
Procedure: Selective Laser trabeculoplasty |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma |
Resource links provided by NLM:
Further study details as provided by Laval University:
Primary Outcome Measures:
- Intraocular pressure in the treated eye [ Time Frame: 1 hour, 7 days, 1.5, 3 and 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period) [ Time Frame: 1 hour, 7 days, 1.5 months, 3 months and 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 138 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Prednisone acetate 1%
A topic cortisone-based treatment
|
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.
|
|
Active Comparator: diclofenac 0.1%
an non-steroidal anti-inflammatory drug
|
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.
|
|
Placebo Comparator: Artificial Tears
Pharmasciences DIN: 02229570
|
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.
|
Detailed 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058278
Locations
| Canada, Quebec | |
| Centre hospitalier universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
Sponsors and Collaborators
Laval University
Canadian Glaucoma Clinical Research Council
Pfizer
Investigators
| Principal Investigator: | Béatrice Des Marchais, MD, F.R.S.C. | Centre hospitalier affilié universitaire de Québec, Laval University |
More Information
No publications provided
| Responsible Party: | Béatrice Des Marchais, Chercheure clinicienne associée, Laval University |
| ClinicalTrials.gov Identifier: | NCT01058278 History of Changes |
| Other Study ID Numbers: | DR-002-1213 |
| Study First Received: | January 27, 2010 |
| Last Updated: | July 3, 2012 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by Laval University:
|
Glaucoma Ocular Hypertension Intraocular Pressure Trabeculectomy |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013