C-Rex Instrument for Glaucoma
(CIRCLE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of the C-Rex instrument for individuals with primary open-angle glaucoma (POAG) who require surgery to lower eye pressure. It examines how the instrument reduces eye pressure and whether it decreases the need for glaucoma medications post-surgery. The trial includes two groups: one combining C-Rex surgery with cataract surgery and another performing it alone. Individuals with primary open-angle glaucoma planning to undergo goniotomy surgery with the C-Rex instrument are suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in glaucoma care.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It mentions collecting data on glaucoma medication use, so you might continue them, but it's best to confirm with the trial coordinators.
What prior data suggests that the C-Rex Instrument is safe for lowering intraocular pressure in glaucoma patients?
Research has shown that the C-Rex surgery, whether performed with cataract removal or on its own, is generally well-tolerated by patients. When combined with cataract surgery, studies indicate that adding goniotomy is safe and improves vision without major issues.
For the standalone C-Rex surgery, early results suggest it effectively reduces eye pressure, which is important for treating glaucoma. Previous studies have not reported any major safety concerns. Overall, both treatment methods appear safe, with few side effects noted.12345Why are researchers excited about this trial?
Researchers are excited about the C-REX™ instrument for treating primary open-angle glaucoma because it offers a unique approach to managing this condition. Unlike traditional treatments like eye drops or laser surgery, which often focus on reducing eye pressure externally, the C-REX™ instrument is used in a goniotomy procedure that directly targets the eye's drainage system. This can potentially enhance fluid outflow and decrease eye pressure more effectively. Additionally, when combined with cataract surgery, it might offer dual benefits for patients needing both interventions, potentially simplifying their surgical experience and recovery.
What evidence suggests that the C-Rex surgery could be effective for primary open angle glaucoma?
This trial will compare two approaches: C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation, and C-Rex surgery as a standalone intervention. Research has shown that combining goniotomy with cataract surgery and lens replacement often improves vision. In one study, 88.2% of patients experienced better vision after the combined surgery. Patients also reported clearer vision with multifocal lenses. Goniotomy alone lowers eye pressure in glaucoma patients, which is important for slowing the disease. Although specific data for standalone C-Rex surgery is not available, its goal is to reduce eye pressure, crucial for managing primary open-angle glaucoma.16789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument
Postoperative Follow-up
Participants are monitored for intraocular pressure (IOP) reduction, use of glaucoma medications, and device-related complications
What Are the Treatments Tested in This Trial?
Interventions
- C-Rex Instrument
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
C-Rex surgery as a standalone intervention
C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Iantrek, Inc.
Lead Sponsor
Citations
Cataract extraction with multifocal intraocular lens ...
Cataract patients who received multifocal IOLs at time of surgery obtained better uncorrected and distance corrected near VA and reported better overall vision.
Cataract extraction with multifocal intraocular lens ...
Cataract patients who received multifocal IOLs at time of surgery obtained better uncorrected and distance corrected near VA and reported better overall vision.
Outcomes of combined cataract extraction, lens ...
Conclusions: Combined surgery outcomes in 456 first-operated eyes of 456 patients showed 88.2% improved visual acuity, 9% re-operation rate, 5.5 mm Hg mean ...
4.
researchgate.net
researchgate.net/publication/348939301_Intraocular_lens_evolution_in_the_past_25_years_as_told_by_the_Journal_of_Cataract_Refractive_SurgeryIntraocular lens evolution in the past 25 years as told by ...
We reviewed the medical records of 66 pediatric cases with intraocular lens (IOL) implantation after cataract extraction and results of ...
Visual Outcomes of Cataract Surgery in Patients with ...
At six months, 71% of eyes gained one or more lines of CDVA, 21% of eyes had no change in lines, and 7% of eyes lost one or more lines of CDVA ( ...
A Real-World Evidence Study of Goniotomy With the C- ...
Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and ...
7.
ctv.veeva.com
ctv.veeva.com/study/a-real-world-evidence-study-of-goniotomy-with-the-c-rex-instrument-in-patients-with-primary-open-anA Real-World Evidence Study of Goniotomy With the C-REX ...
Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive ...
Safety Outcomes Following Implementation of a Systematic ...
Purpose: To evaluate the longitudinal safety outcomes of incorrect intraocular lens (IOL) implantation using a standardized cataract surgery ...
SUMMARY OF SAFETY AND EFFECTIVENESS (SSED)
Implantation is not advisable when the intraocular lens (1OL) may aggravate an existing condition, interfere with the diagnosis or the ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.