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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299281
• Other study ID #: MS 9-222
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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 signi?cant scleral thinning de?ned as thinning of more than one clock hour noticed on scleral transillumination.

• Patients with ongoing ocular infection or inflammation.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Other

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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