An interventional study of Cataract Surgery and CyPass Micro-Stent in Primary Open Angle Glaucoma (POAG) and Cataract, sponsored by Transcend Medical, Inc.. Completed. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Transcend Medical, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.
This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 897 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Transcend Medical, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preoperative Inclusion Criteria:
Exclusion Criteria:
Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery
Procedure: Cataract Surgery · Device: CyPass Micro-Stent
Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
Procedure: Cataract Surgery
Cataract Surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye after completion of cataract surgery.
Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
Time frame: Baseline; Month 24 postoperative
Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
Time frame: Baseline; Month 24 postoperative
Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
Time frame: Month 24 postoperative
Subjects were screened and randomized at 24 investigative sites located in the United States.
| Milestone | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only |
|---|---|---|
| Started | 374 | 131 |
| Completed | 355 | 125 |
| Not completed | 19 | 6 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Subject decision | 4 | 3 |
| Withdrew: Investigator decision | 1 | 1 |
| Withdrew: Death | 11 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
| percentage of eyes | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only |
|---|---|---|
| Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data | 72.5 | 58.0 |
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
| mmHg | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only |
|---|---|---|
| Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data | -7.0 ± 4.53 | -5.3 ± 3.95 |
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
| percentage of eyes | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only |
|---|---|---|
| Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data | 61.2 | 43.5 |
Collected over An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CyPass Micro-Stent + Cataract Surgery | — | 53/374 (14.2%) | 101/374 (27%) |
| Cataract Surgery Only | — | 13/131 (9.9%) | 39/131 (29.8%) |
| Event | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only |
|---|---|---|
| PneumoniaInfections and infestations | 4/374 | 2/131 |
| Cerebrovascular accidentNervous system disorders | 0/374 | 2/131 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/374 | 0/131 |
| Knee arthroplastySurgical and medical procedures | 3/374 | 1/131 |
| Cardiac failure congestiveCardiac disorders | 2/374 | 1/131 |
| Atrial fibrillationCardiac disorders | 0/374 | 1/131 |
| DeathGeneral disorders | 0/374 | 1/131 |
| Urinary tract infectionInfections and infestations | 0/374 | 1/131 |
| Hip fractureInjury, poisoning and procedural complications | 2/374 | 1/131 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/374 | 1/131 |
| Event | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only |
|---|---|---|
| BCVA loss => 10 letters read at/after 3 month postoperative visitEye disorders | 33/374 | 20/131 |
| Worsening in visual field MD by => 2.5 dB as compared with preoperativeNervous system disorders | 25/374 | 13/131 |
| AC cell and flare requiring steroid treatment at/after 30 days postoperativeEye disorders | 32/374 | 5/131 |
| Worsening in any ocular symptom by ≥ 2 points to severe/very severe at/after 3 months postoperativeEye disorders | 21/374 | 4/131 |
| Secondary ocular surgical interventionEye disorders | 20/374 | 7/131 |
All randomized participants (Intent-to-Treat)
| Age, Continuous(years) | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only | Total |
|---|---|---|---|
| Mean | 70.3 ± 8.45 | 70.2 ± 8.17 | 70.3 ± 8.37 |
| Sex: Female, Male(Participants) | CyPass Micro-Stent + Cataract Surgery | Cataract Surgery Only | Total |
|---|---|---|---|
| Female | 197 | 72 | 269 |
| Male | 177 | 59 | 236 |
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Transcend Medical, Inc.