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Completed

NCT Number: NCT05299281

Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients

The study objective was to evaluate the efficacy and safety of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

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Key information

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Other, 13511, Egypt

About this study

Evaluation of the efficacy and safety of a new form of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

In this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in conjunction with a G probe (IRIDEX Medical Instruments, Mountain View, CA, USA).

The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser set on micro- pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of the case and other patient factors. With duty cycle 31.3% (This translates to 0.5 ms "on" time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus greatly reducing thermal damage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients previously diagnosed with glaucoma if they had uncontrolled Intraocular pressure despite maximal tolerated medical therapy.
  • Patients who are unable to maintain compliance with the prescribed topical medications.
  • Patients who need filtering glaucoma surgery for controlling Intraocular pressure but are not generally fit for the surgery.
  • Patients who refused incisional procedures like subscleral trabeculectomy.

Exclusion criteria

  • Patients who were unable to give informed consent.
  • Patients who had undergone previous conventional transscleral diode laser cyclophotocoagulation (TSCPC).
  • Patients with significant scleral thinning defined as thinning of more than one clock hour noticed on scleral transillumination.
  • Patients with ongoing ocular infection or inflammation.

Treatment and study plan

Micropulse transscleral cyclophotocoagulation (MP-TSCPC)

Device

patients undergone micropulse laser transscleral cyclophotocoagulation. The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser radiation set on micro- pulse mode (Iris Medical Instruments, Mountain View, CA, USA), delivered over 100-200 s (envelope of micropulses) depending on severity of the case and other patient factors.

Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively.

Primary outcomes

  1. Intraocular pressure (IOP)

    Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

    significant change in IOP in mmHg.

  2. best corrected visual acuity (BCVA)

    Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

    change in BCVA using snellen's chart

Secondary outcomes

  1. complication rate.

    Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

    Describing any complications related to the procedure.

  2. change in number of postoperative glaucoma medications.

    Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

    Number of postoperative glaucoma medications.

  3. retreatment rate.

    Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

    percentage of patients needing further treatment.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2022
Registry last updated
Mar 29, 2022

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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