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OpenTrials
Completed

NCT Number: NCT02875158

Cyclophotocoagulation in Glaucoma

Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.

The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

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, G1S 4L8, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with poorly controlled high pressure glaucoma
  • Cyclophotocoagulation necessary to prevent visual loss
  • Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort

Exclusion criteria

  • Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
  • Patients receiving concomitant treatment the same day as the intervention
  • Patient not able to follow the prescribed post-operative treatment

Treatment and study plan

Cyclophotocoagulation protocol

Procedure
  • Intravenous route is installed
  • Retrobulbar anaesthesia : 50% xylocaine (2%) + 50% bupivicaine
  • Parameters set for laser treatment (1250mW-4seconds or 2000mW-2 seconds depending on the assigned group)
  • Pars plana measurement using transillumination (if needed)
  • Laser treatment applied approximately 1mm post to limbus
  • Dexamethasone 0,5 mg subconjunctival injection
  • Post-op regimen: Prednisolone 1% qid x 4 weeks, Atropine 1% bid x 2 weeks + Erythromycin ointment + patch x 6h

Conventional cyclophotocoagulation

Procedure

1250 mW for 4 seconds.

Modified cyclophotocoagulation

Procedure

2000 mW for 2 seconds.

Primary outcomes

  1. Intraocular pressure (IOP) evolution

    Time frame: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op

    The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.

Secondary outcomes

  1. Presence of complications

    Time frame: During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op

    Assessment of complications (if applicable).

  2. Use of medication

    Time frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op

    Assessment of the topical and oral glaucoma medication at baseline and after treatment

  3. Retreatment

    Time frame: From the initial treatment up to the last visit (24 months)

    The clinician will assess the need for retreatment based on clinical experience.

  4. Visual acuity

    Time frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op

    The visual acuity will be assessed at baseline and each subsequent visit

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2016
Registry last updated
Sep 11, 2023

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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