Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    tmi-09-01e
Previous Study | Return to List | Next Study

A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial (COMPASS-XT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700984
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Transcend Medical, Inc.
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma (POAG) Device: CyPass Micro-Stent Procedure: Cataract Surgery Not Applicable

Detailed Description:

The COMPASS Trial (TMI-09-01) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study.

The COMPASS-XT (TMI-09-01-E) Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Observational Multicenter Clinical Study to Assess the Long-Term Safety of the CyPass Micro-Stent in Patients With Primary Open Angle Glaucoma Who Have Completed Participation in the COMPASS Trial
Actual Study Start Date : March 30, 2016
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018


Arm Intervention/treatment
Experimental: Cataract Surgery + CyPass
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Device: CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of 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.

Active Comparator: Cataract Surgery Only
Cataract Surgery (COMPASS trial) with no CyPass Micro-Stent implantation
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.




Primary Outcome Measures :
  1. 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group [ Time Frame: Up to Month 60 postoperative ]
    Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.


Secondary Outcome Measures :
  1. Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit [ Time Frame: Baseline, Month 12, 24, 36, 48, 60 postoperative ]
    Best corrected (with spectacles or other visual corrective devices) VA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 1 or 4 meters and determined by total number of letters read correctly. 20/20 Snellen is considered 'normal' vision. A larger denominator indicates a lower visual acuity. Baseline, Month 12, and Month 24 data derived from previous COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  2. Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye [ Time Frame: Up to Month 60 postoperative ]
    Ocular adverse events in the study eye could include, but were not limited to, BCVA loss of 2 lines (10 letters) or more on the ETDRS chart in comparison with the best BCVA reported in Study Protocol TMI-09-01, endophthalmitis, corneal edema, and corneal decompensation. Inferential testing was not planned for this endpoint.

  3. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema [ Time Frame: Month 36, 48, 60 postoperative ]
    Corneal Edema (swelling of the cornea) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (transparent and clear or less than mild), Mild (dull glassy appearance), Moderate (Dull glassy appearance of epithelium with large number of vacuoles), and Severe (epithelial bullae and/or stromal edema, localized or diffuse, with or without stromal striae). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  4. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion [ Time Frame: Month 36, 48, 60 postoperative ]
    Corneal Staining (appearance of tissue disruption and other pathophysiological changes) and erosion (abrasion) were assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (no fluorescein staining of epithelium, OR less than mild), Mild (slight fluorescein staining confined to a small focus), Moderate (regionally dense fluorescein staining (1 mm or greater in diameter) with underlying structure moderately visible), and Severe (marked fluorescein staining or epithelial loss). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  5. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells [ Time Frame: Month 36, 48, 60 postoperative ]
    Inflammatory anterior chamber cells (cells in the front portion of the eye) were assessed by the investigator during slit-lamp examination and reported in one of 6 categories according to cells per 1x1 mm slit: 0-<1 cell, 1-5 cells, 6-15 cells, 16-25 cells, and 26-50 cells, and >50 cells. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  6. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare [ Time Frame: Month 36, 48, 60 postoperative ]
    Anterior Chamber Flare (protein escaping from dilated vessels) was assessed by the investigator during slit-lamp examination and rated on a 5-point scale: None, Faint, Moderate (iris and lens details clear), Marked (iris and lens details hazy), and Intense (fibrin or plastic aqueous). The presence of flare is a sign of intraocular inflammation. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  7. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion [ Time Frame: Month 36, 48, 60 postoperative ]
    Iris Atrophy/Erosion (deterioration) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  8. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking [ Time Frame: Month 36, 48, 60 postoperative ]
    Iris Peaking (one part of the iris pulled to a peak resulting in an irregular pupil) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  9. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis [ Time Frame: Month 36, 48, 60 postoperative ]
    Iris Rubeosis (abnormal blood vessels (formed by neovascularization) found on the surface of the iris) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  10. Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity [ Time Frame: Month 36, 48, 60 postoperative ]
    PCO (cloudy layer of scar tissue behind the lens implant) Severity was assessed by the investigator during slit-lamp examination and rated on a 6-point scale: None, Minimal, Mild, Moderate, Severe, and Unspecified. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  11. Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only [ Time Frame: Month 36, 48, 60 postoperative ]
    For subjects in the CyPass group, gonioscopic examination was performed to assess the position of the CyPass Micro-Stent in the angle and with respect to the iris and the corneal endothelium. A visible CyPass Micro-Stent indicated a lack of adhesions (favorable). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  12. Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations [ Time Frame: Month 36, 48, 60 postoperative ]
    The dilated fundus examination was performed by the investigator to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. Clinically significant findings are reported categorically. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  13. Change From Month 24 in Visual Field Mean Deviation [ Time Frame: Month 24, 36, 48, 60 postoperative ]
    Visual field (how much one can see to each side while focusing the eyes on a central point (peripheral vision)) deviations were obtained with a Humphrey automated perimeter using the 24-2 SITA standard testing method. Normal deviation values are typically within 0 to -2 decibels (dB) and become more negative as the overall field worsens. Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  14. Change From Month 24 in Central Corneal Thickness [ Time Frame: Month 24, 36, 48, 60 postoperative ]
    Central corneal thickness was evaluated by Pachymetry and measured in micrometers (μm). A negative number indicates a decrease in corneal thickness (unfavorable). Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  15. Central Corneal Endothelial Cell Density (ECD) by Visit [ Time Frame: Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative ]
    The endothelium maintains corneal hydration and reduced cell density can disrupt vision. Central endothelial cell counts were assessed using non-contact specular microscopy. Specular images were taken of the corneal endothelium and submitted to a reading center in order to standardize readings across all sites and optimize reading reliability. Baseline through Month 24 data were derived from COMPASS trial. A higher cell density indicates improvement. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  16. Number of Subjects With CyPass Device Malposition, Dislodgement or Movement [ Time Frame: Up to 60 months postoperatively ]
    Device position was a qualitative and subjective assessment by the investigator and evaluated based on visible number of rings of the device under the gonioscopic exam. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. This outcome measure was prespecified for Cataract Surgery + CyPass arm only.

  17. Mean Reduction From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Month 36, 48, 60 postoperative ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher reduction from baseline (ie, a greater postitive number) indicates greater improvement. Baseline was derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  18. Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications [ Time Frame: Baseline, Month 36, 48, 60 postoperative ]
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.

  19. Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg [ Time Frame: Month 36, 48, 60 postoperative ]
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completed the COMPASS Trial
  2. Understands study requirements and is willing to follow study instructions and return for study visits

Exclusion Criteria:

  1. Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
  2. Early termination from the COMPASS Trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700984


Locations
Layout table for location information
United States, Arizona
Alcon Investigative Site
Glendale, Arizona, United States, 85306
United States, Arkansas
Alcon Investigative Site
Fayetteville, Arkansas, United States, 72704
United States, California
Alcon Investigative Site
La Jolla, California, United States, 92037
Alcon Investigative Site
Orange, California, United States, 92868
United States, Colorado
Alcon Investigative Site
Fort Collins, Colorado, United States, 80525
Alcon Investigative Site
Parker, Colorado, United States, 80134
United States, Florida
Alcon Investigative Site
Boynton Beach, Florida, United States, 33426
Alcon Investigative Site
Cape Coral, Florida, United States, 33904
United States, Iowa
Alcon Investigative Site
Sioux City, Iowa, United States, 51104
United States, Kansas
Alcon Investigative Site
Garden City, Kansas, United States, 67846
United States, Massachusetts
Alcon Investigative Site
Boston, Massachusetts, United States, 02111
United States, Missouri
Alcon Investigative Site
Saint Louis, Missouri, United States, 63131
United States, New Jersey
Alcon Investigative Site
Vineland, New Jersey, United States, 08361
United States, Ohio
Alcon Investigative Site
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Alcon Investigative Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Alcon Investigative Site
Kingston, Pennsylvania, United States, 18704
Alcon Investigative Site
West Mifflin, Pennsylvania, United States, 15122
United States, Tennessee
Alcon Investigative Site
Maryville, Tennessee, United States, 37803
Alcon Investigative Site
Nashville, Tennessee, United States, 37232
United States, Texas
Alcon Investigative Site
Dallas, Texas, United States, 75231
Alcon Investigative Site
Fort Worth, Texas, United States, 76102
Alcon Investigative Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Alcon Research
Transcend Medical, Inc.
Investigators
Layout table for investigator information
Study Director: Alcon, Research Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] October 26, 2016
Statistical Analysis Plan  [PDF] February 18, 2018

Additional Information:
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02700984    
Other Study ID Numbers: TMI-09-01-E
GLD122b-C001 ( Other Identifier: Alcon )
First Posted: March 7, 2016    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases