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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Other
    • Banhā, Other, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Glaucoma patients; Patients were enrolled from outpatient clinic with glaucoma during the period between January 2020 and July 2021

Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP)	significant change in IOP in mmHg.	Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
best corrected visual acuity (BCVA)	change in BCVA using snellen's chart	Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Gehad H Youssef, Msc, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: micropulse laser; glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: MS 9-222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No