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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-reinforced Cyclodialysis in conjunction with cataract surgery | Cataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System |
| |
| Bio-reinforced Cyclodialysis alone | Bio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CycloPen Micro-Interventional Cyclodialysis System | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in intraocular pressure (IOP) | Mean change in intraocular pressure (IOP) measured using tonometry | From before bio-interventional cyclodialysis to 60 months after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in number of IOP-lowering medications used | Mean change in the number of IOP-lowering medications used | From before bio-interventional cyclodialysis to 60 months after surgery |
| Percent change in intraocular pressure (IOP) |
Inclusion Criteria:
Exclusion Criteria:
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Participants are undergoing treatment for glaucoma at medical clinics located in the United States
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho Ianchulev, MD, MPH | Iantrek, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CREST-XT Site 05 | Newport Beach | California | 92663 | United States | ||
| CREST-XT Site 03 |
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| CycloPen Micro-Interventional Cyclodialysis System Post Cataract | Procedure | 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 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
| 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 | From before bio-interventional cyclodialysis to 60 months after surgery |
| Cape Coral |
| Florida |
| 33904 |
| United States |
| CREST-XT Site 07 | Atlanta | Georgia | 30342 | United States |
| CREST-XT Site 12 | Chevy Chase | Maryland | 20815 | United States |
| CREST-XT Site 13 | Rockville | Maryland | 20852 | United States |
| CREST-XT Site 16 | Las Vegas | Nevada | 89145 | United States |
| CREST-XT Site 15 | New York | New York | 10034 | United States |
| CREST-XT Site 01 | Fort Washington | Pennsylvania | 19034 | United States |
| CREST-XT Site 04 | Crossville | Tennessee | 38555 | United States |
| CREST-XT Site 11 | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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