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

Study Overview
=================
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.

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

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glaucoma patients<br>Patients were enrolled from outpatient clinic with glaucoma during the period between January 2020 and July 2021 | Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, micropulse laser