An observational study in Open-angle Glaucoma (OAG), sponsored by Iantrek, Inc.. Enrolling by invitation at 10 sites in United States. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Iantrek, Inc. · Observational
This study is designed to collect clinical data at 3, 4, and 5 years postoperatively for participants who completed the CREST Study without having secondary IOP-lowering surgery in the study eye(s).
This is a multicenter, prospective, observational study following eligible participants who completed the CREST Study. Participants who consent to participate will have clinical data gathered from annual ophthalmic examinations through 60 months after CycloPen System surgery for analysis of long-term outcomes. As an observational study, examinations at each visit are performed per the investigator's standard of care.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 250 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Iantrek, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are undergoing treatment for glaucoma at medical clinics located in the United States
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System
Procedure: CycloPen Micro-Interventional Cyclodialysis System Post Cataract
Bio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System
Procedure: CycloPen Micro-Interventional Cyclodialysis System
The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.
After cataract surgery, the CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.
Mean change in intraocular pressure (IOP)
Mean change in intraocular pressure (IOP) measured using tonometry
Time frame: From before bio-interventional cyclodialysis to 60 months after surgery
Mean change in number of IOP-lowering medications used
Mean change in the number of IOP-lowering medications used
Time frame: From before bio-interventional cyclodialysis to 60 months after surgery
Percent change in intraocular pressure (IOP)
Mean percent change in IOP in comparison with baseline (prior to surgery), while using the same or fewer IOP-lowering medications and without additional IOP-lowering surgical or laser procedures
Time frame: From before bio-interventional cyclodialysis to 60 months after surgery
Percent of eyes with ≥ 20% decrease in intraocular pressure (IOP)
Proportion of eyes with postoperative IOP ≥ 20% lower than baseline (prior to surgery), while using the same or fewer IOP-lowering medications and without additional IOP-lowering surgical or laser procedures
Time frame: From before bio-interventional cyclodialysis to 60 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Iantrek, Inc.