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Completed

NCT Number: NCT07591662

Subthreshold Diode Laser Versus Trabeculotomy in Treatment of Advanced Primary Open Angle Glaucoma

This study aimed to compare between subthreshold diode laser and trabeculotomy in treatment of advanced primary open angle glaucoma throughout 12 months follow-up.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

Glaucoma is a common eye disease that can cause irreversible blindness if left undiagnosed and untreated. Glaucoma is caused by elevated intraocular pressure (IOP) that leads to optic nerve damage and visual field loss.

Trabeculectomy operation was first described more than 50 years ago and is considered the most commonly performed surgery worldwide for glaucoma patients.

Subthreshold transscleral cyclophotocoagulation is a micropulse delivery mode of diode laser that has been used recently to treat glaucoma by ablating the ciliary processes and reducing the aqueous humour production.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18 years.
  • Open angle glaucoma.
  • Advanced glaucoma (visual field deterioration MD>-12.00 dB with evidence of optic neuropathy despite maximal therapy).

Exclusion criteria

  • Previous intraocular surgery for glaucoma.
  • Patients who had undergone previous laser therapy for glaucoma.
  • Cases of secondary glaucoma.
  • Media opacity interferes with capturing fundus image.

Treatment and study plan

Subthreshold diode laser

Procedure

Patients scheduled for subthreshold diode laser.

Trabeculotomy

Procedure

Patients scheduled for trabeculotomy.

Primary outcomes

  1. Visual acuity

    Time frame: 12 months postoperatively

    Visual acuity was evaluated using finger counting, hand motion, or light perception

Secondary outcomes

  1. Intraocular pressure

    Time frame: 12 months postoperatively

    Intraocular pressure was measured and success criteria included an IOP ranging from 6 to 21 mmHg or a minimum 20% decline from baseline, with or without antiglaucoma drugs.

  2. Degree of pain

    Time frame: 12 months postoperatively

    Postoperative pain was assessed using a visual analogue scale from 0 to 10 cm: 0-4 cm for mild, 5-7 cm for moderate, and 8-10 cm for intense pain.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 18, 2026
Registry last updated
May 18, 2026

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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