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

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Micropulse transscleral cyclophotocoagulation (MP-TSCPC)

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, micropulse laser

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Benha University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Glaucoma patients

Arm Description

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

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP)

significant change in IOP in mmHg.

best corrected visual acuity (BCVA)

change in BCVA using snellen's chart

Secondary Outcome Measures

complication rate.

Describing any complications related to the procedure.

change in number of postoperative glaucoma medications.

Number of postoperative glaucoma medications.

retreatment rate.

percentage of patients needing further treatment.

Full Information

NCT ID

NCT05299281

First Posted

March 9, 2022

Last Updated

March 17, 2022

Sponsor

Benha University

1. Study Identification

Unique Protocol Identification Number

NCT05299281

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

July 1, 2021 (Actual)

Study Completion Date

July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

glaucoma, micropulse laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glaucoma patients

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Micropulse transscleral cyclophotocoagulation (MP-TSCPC)

Intervention Description

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 Outcome Measure Information:

Title

Intraocular pressure (IOP)

Description

significant change in IOP in mmHg.

Time Frame

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

Title

best corrected visual acuity (BCVA)

Description

change in BCVA using snellen's chart

Time Frame

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

Secondary Outcome Measure Information:

Title

complication rate.

Description

Describing any complications related to the procedure.

Time Frame

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

Title

change in number of postoperative glaucoma medications.

Description

Number of postoperative glaucoma medications.

Time Frame

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

Title

retreatment rate.

Description

percentage of patients needing further treatment.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gehad H Youssef, Msc

Organizational Affiliation

Benha University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Benha University

City

Banhā

State/Province

Other

ZIP/Postal Code

13511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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