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

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05299281
Collaborator
(none)
40
1
1
18
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Benha University Banhā Other Egypt 13511

Sponsors and Collaborators

  • Benha University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gehad Hassan Abdelhalim Mohamed Youssef, Assisstant lecturer of ophthalmology, Benha University
ClinicalTrials.gov Identifier:
NCT05299281
Other Study ID Numbers:
  • MS 9-222
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gehad Hassan Abdelhalim Mohamed Youssef, Assisstant lecturer of ophthalmology, Benha University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022