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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)

• Registration Number: NCT05299281
• Lead Sponsor: Benha University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucoma patients	Micropulse transscleral cyclophotocoagulation (MP-TSCPC)	Patients were enrolled from outpatient clinic with glaucoma during the period between January 2020 and July 2021

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively	significant change in IOP in mmHg.
best corrected visual acuity (BCVA)	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 Outcome Measures

Name	Time	Method
complication rate.	Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively	Describing any complications related to the procedure.
change in number of postoperative glaucoma medications.	Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively	Number of postoperative glaucoma medications.
retreatment rate.	Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively	percentage of patients needing further treatment.

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, Other, Egypt