Clinical trial NCT02627352: How Safe and Effective is Micropulse Transscleral Cyclophotocoagulation in Patients With Uncontrolled Glaucoma?
Official title: Prospective Evaluation of the New Micropulse Transscleral Cyclophotocoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Micropulse Transscleral Cyclophotocoagulation
Intraocular Pressure
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diode Laser Cyclophotocoagulation
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the surgical outcomes of the micropulse transscleral cyclophotocoagulation (mTSCPC) in patients with uncontrolled glaucoma; analyze intraocular pressure lowering effect; and correlate related treatment parameters pending enrollment of sufficient numbers of dark pigmented versus light pigmented eyes.

Detailed description: If the subject agrees to participate in this study, he/she will come in for a screening visit to make sure they qualify for the study. Following the surgical procedure, principal investigator will perform a standard postoperative examination at Day 1, Week 1, Month

1, Month 3, Month 6 and Month 12, in addition to any other visits the investigator feels may be necessary.

Screening Visit: At the screening visit, the subjects medical history and current medications will be reviewed. Pre-operative eye pressure and visual acuity will be noted. The Kowa Flare Meter-500 laser flare meter and slit lamp (the table-top microscope used for examining the eye) will be used to measure inflammation in subjects anterior chamber (the fluid-filled space between the iris (colored part of the eye) and cornea (clear front part of the eye that covers the iris and pupil).

Surgery: On the day of the subjects surgery, the subject will undergo the standard procedure for transscleral cyclophotocoagulation (TSCPC) laser surgery using the micropulse delivery mode of diode laser. After the Principal investigator finishes with the laser, he/she will perform anterior chamber paracentesis, which will help reduce the pressure in the subjects eye quickly and temporarily. To do this, the principal investigator will puncture the cornea (the clear front part of the eye that transmits and focuses light into the eye) to remove some of the aqueous (fluid inside the eye). Paracentesis is usually not done if TSCPC is performed using the "continuous" delivery mode.

Post-Operative Exams: At each of the post-operative office visits (Day 1, Week 1, Months 1, 3, 6 and 12) a detailed medical/eye history will be taken, including all current medications, vision will be tested and an eye examination will be performed, including measurement of eye pressure. Subject will be asked about his/her comfort level in regards to pain. At visit Day 1 and Month 1 the amount of anterior chamber inflammation will again be measured (as described in Screening Visit).

Eligibility criteria: Inclusion Criteria: Patients with a minimum of 6 months follow-up with uncontrolled glaucoma as defined by:

* Progression and/or intraocular pressure above target despite maximal tolerated medical therapy
* Evidence of glaucomatous optic nerve damage and glaucomatous visual field loss in at least one hemifield

Exclusion Criteria:

* Age ≤ 20 years old.
* Patients who had undergone previous intraocular surgery or ocular laser treatment within 2 months of enrolment.
* Patients who had undergone previous conventional continuous wave mode TSCPC within 1 months of enrolment.
* Patients with significant scleral thinning as defined by greater than 1 clock hour.
* Patients with any medical condition that would preclude the subject from providing informed consent or reliable and valid data.
* Patients enrolled in other prospective clinical trials.
* Albino patients that have no pigmentation

Primary outcomes:
measure: Intraocular pressure-lowering effect
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute, Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Marlene R Moster, MD
role: PRINCIPAL_INVESTIGATOR
References: