|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02226094 |
|
Date of registration:
|
20/08/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension
|
|
Scientific title:
|
A Prospective, Randomized, Controlled Clinical Feasibility Investigation of the Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects |
|
Date of first enrolment:
|
November 2013 |
|
Target sample size:
|
35 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02226094 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Philippines
| | | | | | | |
|
Contacts
|
|
Name:
|
Edgar U. Leuenberger, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Asian Eye Institute |
|
|
Name:
|
Harvey Siy Uy, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pacific Eye and Laser Institute |
|
|
Name:
|
Maria I Yap-Veloso, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Asian Eye Institute |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male or female subjects, 18 years or older.
- Subjects diagnosed with either POAG or OHT in both eyes. The diagnosis of POAG must
include evidence of:
1. Optic disc or retinal nerve fiber layer structural abnormalities (substantiated
by OCT); and/or
2. Visual field abnormality (substantiated with the Humphrey automated perimeter
using the SITA Standard 24-2 testing algorithm. Mean deviation (MD) score must be
-15dB < MD < 0dB.
- Subjects with a 9:00AM (+/- 1 hour) median IOP in both eyes that is:
1. Greater than or equal to 18mmHg at the Screening Visit or have documented history
of IOP being greater than or equal to 22mmHg;
2. Greater than or equal to 22mmHg at both Eligibility Visits.
- Subjects currently using one or more topical medications to control their IOP.
- Subjects able and willing to comply with the protocol, including randomization
assignment and all follow-up visits.
- Subjects that sign the informed consent form.
Exclusion Criteria:
- Subjects who are pregnant, lactating, or planning to become pregnant during the course
of the study.
- Subjects with any form of glaucoma other than primary open-angle glaucoma (e.g.,
pseudo exfoliation or pigmentary glaucoma).
- Other exclusion criteria apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Ocular Hypertension (OHT)
|
|
Primary Open-angle Glaucoma (POAG)
|
|
Intervention(s)
|
|
Device: DWT sham
|
|
Device: Ellex Tango SLT machine
|
|
Device: DWT device dose A
|
|
Device: DWT device dose B
|
|
Primary Outcome(s)
|
|
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
[Time Frame: 6 months]
|
|
Intra-procedural and post-procedural adverse events
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
DWT CIP 002
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|