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

NCT05299281 | Completed DMC

• 1 other identifier: MS 9-222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; micropulse laser

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• complication rate.

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

• change in number of postoperative glaucoma medications.

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

• retreatment rate.

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

Study Arms (1)

Glaucoma patients

OTHER

Patients were enrolled from outpatient clinic with glaucoma during the period between January 2020 and July 2021

Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)

Interventions

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.

Glaucoma patients

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Other, 13511, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Gehad H Youssef, Msc

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer of ophthalmology

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 29, 2022
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)