NCT04709679

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

January 12, 2021

Last Update Submit

June 28, 2022

Conditions

Glaucoma

Keywords

MP-TSCPCLaser DurationLaser Dwell timeLaser Power

Outcome Measures

Primary Outcomes (1)

  • Changes in intraocular pressure measurements between baseline and postoperative followup visits

    Baseline (pre-operative condition) and post operative intraocular pressure will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.

    2years

Secondary Outcomes (3)

  • Changes in visual acuity measurements measured using a Snellen Vision Chart between baseline and postoperative followup visits

    2 years

  • Changes in number of medications between baseline and postoperative followup visits

    2 years

  • Rate of post surgical complications

    2 years

Study Arms (3)

Constant dwell time but varying power and duration

EXPERIMENTAL

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

Procedure: MicroPulse TransScleral CycloPhotoCoagulation

Constant power but varying dwell time and duration

EXPERIMENTAL

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

Procedure: MicroPulse TransScleral CycloPhotoCoagulation

Constant duration but varying dwell time and power

EXPERIMENTAL

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

Procedure: MicroPulse TransScleral CycloPhotoCoagulation

Interventions

MicroPulse TransScleral CycloPhotoCoagulationPROCEDURE

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 powerConstant dwell time but varying power and durationConstant power but varying dwell time and duration

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Sandra F Sieminski, MD

    Ross Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

January 1, 2021

Primary Completion

October 11, 2021

Study Completion

October 11, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)