Clinical trial NCT05299281: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
micropulse laser
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
measure: best corrected visual acuity (BCVA)
timeFrame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
Secondary outcomes:
measure: complication rate.
timeFrame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
measure: change in number of postoperative glaucoma medications.
timeFrame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
measure: retreatment rate.
timeFrame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Other
Study officials:
affiliation: Benha University
name: Gehad H Youssef, Msc
role: PRINCIPAL_INVESTIGATOR
References: