Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05949242 |
| Other study ID # |
76998263 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2023 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Ridge Eye Care |
| Contact |
Douglas McGraw, DO |
| Phone |
520-247-0635 |
| Email |
rock-n-run[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to look at the difference in pressure lowering effects in
patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at
the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and
be candidates for cataract surgery. The trial will look at the eye pressure before and one
year after cataract surgery in patients. One eye in each patient will have cataract surgery
with canaloplasty using OMNI. The patients other eye will have cataract surgery with
canaloplasty and a HYDRUS stent. The trial will look at the differences in eye pressure and
if patients are able to need fewer eye pressure lowering drops after surgery.
Study participants will undergo preop testing of pressure, vision, slit lamp exam, ocular
coherence tomography (OCT) of the nerve fiber layer (NFL) analysis, and visual field prior to
cataract surgery with MIGS. One day, one week, one month, 6 month, and 1 year exams will be
performed to check pressure, vision, slit lamp exam, and number of necessary eye pressure
medications in each eye.
Description:
The purpose of this research study is to:
· Determine the differing pressure lowering effects between OMNI canaloplasty alone versus
when combined with HYDRUS microstent. Both surgical study devices are widely used by
themselves in conjunction with cataract surgery. While many surgeons have begun combining the
two procedures, this will be one of the first studies to randomize (assign by chance) one eye
to OMNI canaloplasty alone and the other eye to OMNI canaloplasty with HYDRUS stent and
report the results after one year.
About 80 subjects aged 18 years and older will participate in this study.
WHAT WILL HAPPEN DURING THE STUDY?
Your participation in this study will last approximately one year and will include
approximately seven study visits to the study center and two visits to the surgery center.
Screening:
Before any study-related tests and procedures are performed, you will be asked to read and
sign this consent document. The following screening tests and procedures will then be
performed to determine if you qualify to take part in this study:
- Visual field
- OCT analysis of the nerve and cornea - your nerve and cornea will be measured using
optical coherence tomography (OCT) equipment. This is painless, non-invasive (it does
not involve puncturing or cutting) and is similar to having photographs taken of your
eye. You will be required to sit still during the brief scanning procedure (a few
seconds)
- Slit lamp exam with gonioscopy - a close inspection of the front of the eye using a
machine that magnifies the eye and provides a beam of light to light the structures of
the eye
- Eye pressure test - measurement of the pressure inside the eye. The pressure in your
eyes will be measured using an instrument known as a tonometer
- Visual acuity test - a test involving reading letters off a chart to determine how well
you can see
This study will use competitive enrollment. This means that when a target number of subjects
begins the study, all further enrollment will be closed. Therefore, it is possible that you
could be
in the screening phase, ready to begin the study, and be discontinued without your consent if
the target number of subjects has already begun the study.
If you qualify to take part in this study and go on to receive the study treatment, then the
following will happen:
Washout Period: You will be asked to stop taking your eye drops to treat your glaucoma. This
is called a washout period, during which the effects of these medications leave your body.
Study Treatment: You will be randomly assigned by chance (like the flip of a coin) to receive
either OMNI canaloplasty or OMNI canaloplasty with HYDRUS microstent. You will have a 50% (1
in 2) chance of receiving OMNI canaloplasty alone or OMNI canaloplasty with HYDRUS
microstent. This is a not a blinded study, which means that you, the study doctor, study
staff and the sponsor will know the study treatment you are given.
You will have the following study visits and undergo the following procedures:
· Preoperative and postoperative care will be the same as a standard cataract surgery
consisting of one day, one week, one month, six month and one year follow-up exams. The only
difference for study subjects is they will be asked to stop all glaucoma drops one month
prior to their pre-op exam and one year post-op exam.
After Study Treatment:
Glaucoma is a permanent and irreversible condition that requires lifelong monitoring with an
eye care professional. Sometimes additional treatment is required. Your eye specialist will
recommend follow-up care based on your personal findings.
