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OpenTrials
Completed

NCT Number: NCT01058278

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, Quebec, G1S 4L8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selective Laser Trabeculoplasty

Procedure

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.

Primary outcomes

  1. Intraocular pressure in the treated eye

    Time frame: 1 hour, 7 days, 1.5, 3 and 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Glaucoma Clinical Research Council
  • Pfizer

Registry information

Official study title

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

Acronym: SLT

Important dates

Study start
2008
Primary completion
2012
Study completion
2015
First posted
Jan 28, 2010
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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