How Safe and Effective is Micropulse Transscleral Cyclophotocoagulation in Patients With Uncontrolled Glaucoma?

NCT02627352 | Completed DMC

• 1 other identifier: 14-439
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Glaucoma; Micropulse Transscleral Cyclophotocoagulation; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure-lowering effect

  The primary outcome measure will be treatment success, defined by an intraocular pressure (IOP) between 5 and 21mmHg (millimeters of mercury) or a 20% reduction from baseline with or without the addition of anti-glaucoma medications. Within the success group there will be sub-categories of ''qualified success" defined as achieving target IOP with the aid of anti-glaucoma medications.

  2 years

Study Arms (1)

Transscleral Cyclophotocoagulation

EXPERIMENTAL

Subjects undergo a Micropulse Transscleral Cyclophotocoagulation(TSCPC) laser surgery, where a diode laser is used to damage tissue of the ciliary body, the tissue inside the eye that produces aqueous, the clear fluid in the eye that maintains intraocular pressure. This causes it to produce less aqueous.

Procedure: Micropulse Transscleral Cyclophotocoagulation

Interventions

Micropulse Transscleral Cyclophotocoagulation PROCEDURE

In mTSCPC, a diode laser is used to damage tissue of the ciliary body, the tissue inside the eye that produces aqueous, the clear fluid in the eye that maintains intraocular pressure. This causes it to produce less aqueous.

Also known as: mTSCPC

Transscleral Cyclophotocoagulation

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Marlene R Moster, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Diode Laser Cyclophotocoagulation

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)