Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04709679
Status:
TERMINATED
Last Update Posted:
2022-07-01
First Post:
2021-01-12
Brief Title:
Laser Dosage in MicroPulse TransScleral CycloPhotocoagulation
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Clinical Outcome of Varying Doses of Micropulse TransScleral CycloPhotocoagulation Laser in Patients With Glaucoma
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dose was not therapeudic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 ms duration of on-time and 11 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 313 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 secondshemifield
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
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 05 ms duration of on-time and 11 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 313 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 secondshemifield
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None