Laser Dosage in MicroPulse TransScleral CycloPhotocoagulation

NCT ID: NCT04709679

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-10-11

Brief Summary

This is a prospective study to evaluate the clinical outcome of varying doses of Micropulse TransScleral CycloPhotocoagulation (MP-TSCPC) laser in patients with glaucoma. The study will assess documented complication rates, changes in visual acuity after the procedure, changes in intraocular pressures and medication drop usage, and need for subsequent treatments (including further laser or surgery).

Detailed Description

Glaucoma is a condition where an increase in the accumulation of aqueous humor inside the anterior chamber of the eye results in raised intraocular pressure (IOP), visual field defects and cupping of optic disc. Typically, patients who have glaucoma are treated with topical medications or incisional surgery to lower the IOP. Micropulse transscleral cyclophotocoagulation (MP-TSCPC) is a non-incisional laser surgery used in the treatment of glaucoma. MP-TSCPC powered by the Cyclo G6 (Iridex Corporation, Mountain View, CA, USA) causes mild thermal damage to the ciliary body (gland that produces aqueous fluid in the eye), which, in turn, causes a decrease in intraocular pressure. MP-TSCPC is a variation of a longstanding older treatment for glaucoma, traditional diode TSCPC, which caused a significant amount of tissue damage and therefore was reserved for the treatment of end stage glaucoma.

The micropulse laser application includes an on-off cycle. In an on cycle, the micropulse probe administers a short pulse of laser energy followed by an off cycle which is a rest period for the tissue to cool off before the next on-off cycle begins. This corresponds to 0.5 ms duration of "on-time" and 1.1 ms interval of "off-time" during the laser application. This on-off cycle allows for the laser to treat the affected area without evidence of tissue damage, as opposed to the traditional diode TSCPC. Because only 31.3% of the total laser energy is applied to the ciliary body, there is a less tissue damage, less post-operative inflammation, and decreased complication rates. Therefore, MP-TSCPC is currently being utilized for milder cases of glaucoma, and in patients with viable vision. The laser probe is usually applied perpendicular to the limbus in a continuous sweeping motion, for an average of 10 seconds of sweeping time per hemifield, referred to as "dwell time". Therefore, the three parameters that can be varied in the treatment with MP-TSCPC are total laser duration (seconds), laser power (mW) and dwell time (seconds/hemifield).

Most of the studies used a laser power of 2000 - 2500 mW. The laser duration also has varied between studies. A duration time of 50 to 180 sec per hemisphere was used in different studies. Most studies have utilized a dwell time of 10 seconds per hemifield, and one cited an application of a "stop and go" method, applying the laser in discrete spots at 10 seconds each.

In all of the prior studies, despite the variable applications of power, dwell time, and duration, there have been similar rates of complications such as vision loss, macular edema, and hypotony. Generally, the laser duration is tailor-made and is adjusted based on the iris color and severity of glaucoma. However, there is a gap in knowledge on systematic comparison of different doses of MP-TSCPC for a safe and effective treatment of glaucoma. This study will systematically evaluate the clinical outcome of glaucoma surgery based on a logical variation of MP-TSCPC laser dosing parameters.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Constant dwell time but varying power and duration

The laser dwell time will be constant but the laser power and duration will be varied for patients

Group Type: EXPERIMENTAL

MicroPulse TransScleral CycloPhotoCoagulation

Intervention Type: PROCEDURE

A laser power of 2000- 2500 mW, a laser duration time of 50 to 80 sec per hemifield and varying da number of sweeps per hemifield 3, 4 or 5 will be randomized between patients

Constant power but varying dwell time and duration

The laser power will be constant but the laser dwell time and duration will be varied for patients

Group Type: EXPERIMENTAL

MicroPulse TransScleral CycloPhotoCoagulation

Intervention Type: PROCEDURE

A laser power of 2000- 2500 mW, a laser duration time of 50 to 80 sec per hemifield and varying da number of sweeps per hemifield 3, 4 or 5 will be randomized between patients

Constant duration but varying dwell time and power

The laser duration will be constant but the laser dwell time and power will be varied for patients

Group Type: EXPERIMENTAL

MicroPulse TransScleral CycloPhotoCoagulation

Intervention Type: PROCEDURE

A laser power of 2000- 2500 mW, a laser duration time of 50 to 80 sec per hemifield and varying da number of sweeps per hemifield 3, 4 or 5 will be randomized between patients

Interventions

MicroPulse TransScleral CycloPhotoCoagulation

A laser power of 2000- 2500 mW, a laser duration time of 50 to 80 sec per hemifield and varying da number of sweeps per hemifield 3, 4 or 5 will be randomized between patients

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Decision to treat by MP-TSCPC Laser
• Patients diagnosed with Glaucoma
• Patients aged 18 years old and above
• Glaucoma that is inadequately controlled on medical therapy
• Patients with primary open angle glaucoma with or without previously failed trabeculectomy or other aqueous drainage surgical procedures

Exclusion Criteria

• Patients age less than 18 years
• Patients unable or unwilling to provide informed consent to participate in the study
• Patients potentially unavailable for follow up visits
• Patients with significant scleral thinning
• Patients with ocular infection, inflammation or intraocular surgery in the study eye 2 months prior to enrollment in the study
• Albino patients that have no iris pigmentation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRIDEX Corporation

UNKNOWN

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Sandra Sieminski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra F Sieminski, MD

Role: PRINCIPAL_INVESTIGATOR

Ross Eye Institute

Locations

The Ira G. Ross Eye Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

STUDY00003149

Identifier Type: -

Identifier Source: org_study_id