Skip to main content
OpenTrials
Completed

NCT Number: NCT05230355

Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

The aim of this study is to assess the results of subliminal subthreshold transscleral diode cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree application and to compare the outcome with a modified technique both in terms of efficacy and safety.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, 71515, Egypt

About this study

Refractory glaucoma is glaucoma that doesn't respond favorably to surgical and/or medical treatment to lower intraocular pressure. It can include primary open angle glaucoma, primary angle closure glaucoma, neovascular glaucoma or silicone oil-induced glaucoma. Cyclophotocoagulation (CPC) is a form of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. Transscleral cyclophotocoagulation using a continuous diode laser has been a treatment option in advanced glaucoma cases with s¬¬uboptimal IOP control, for a long time. High treatment energy used by diode laser cyclophotocoagulation was argued to be associated with increased frequency of serious complications such as vision loss, hypotony, and phthisis. These concerns necessitate modulation of the parameters of laser treatment used.

Micropulse transscleral cyclophotocoagulation (MP-TSCPC), which is a variation of conventional continuous-wave CPC, has emerged as an attractive alternative for the treatment of many types of glaucoma. It breaks the continuous wave laser into multiple short and repetitive pulses that allow the tissue to cool down between applications, thus reducing thermal damage. This strategy delivers very short energy pulses followed by rest periods, which is known as "duty cycle" and is defined as the ratio of time that a laser is delivering energy vs resting (ON/OFF). For this procedure, an infrared diode laser is used to stimulate the ciliary body structures and the uveoscleral pathway. This way it reduces the production of the aqueous humour and facilitates the uveoscleral outflow, with IOP reduction as a final effect.

Despite promising results, only few clinical studies are published on MP-TSCPC and most of them are retrospective studies refer to patients having previous continuous wave transscleral cyclophotocoagulation. Moreover, Several parameters and protocols have been studied in other reports in an attempt to refine the standard technique aiming to improve the outcomes without increasing the adverse effects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with refractory glaucoma (IOP > 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both)

Exclusion criteria

  • Ocular inflammation.
  • Ocular infection.
  • Recent ocular surgery in the study eye in the 2 months prior to enrolment.

Treatment and study plan

standard technique

Device

The probe was moved over each hemisphere for 120 seconds (a total of 240 seconds). Total energy = 2.5 x 0.313 x 240 = 187.8 J

modified pattern

Device

The probe was moved over 3 quadrants for 80 seconds for each quadrant (a total of 240 seconds). Total energy = 2.5 x 0.313 x 240 = 187.8 J

Primary outcomes

  1. IOP reduction success rate

    Time frame: 6 months

    Success rate is defined as achieving an IOP between 5 and 21 mmHg or at least a 20% reduction in IOP at the final follow up with or without IOP lowering medications

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 8, 2022
Registry last updated
Jul 10, 2025

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.

Published trials that share one or more normalized conditions with this study.