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

October 9, 2017 updated by: Marlene Moster, MD, Wills Eye

Prospective Evaluation of the New Micropulse Transscleral Cyclophotocoagulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute, Glaucoma Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transscleral Cyclophotocoagulation
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
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.
Other Names:
  • mTSCPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure-lowering effect
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Investigators

  • Principal Investigator: Marlene R Moster, MD, Wills Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

A manuscript has been submitted for publication.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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