Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery (COMPASS)

• ClinicalTrials.gov Identifier: NCT01085357
• Recruitment Status: Completed
• First Posted: March 11, 2010
• Results First Posted: October 20, 2016
• Last Update Posted: May 15, 2017
• Sponsor: Transcend Medical, Inc.
• Information provided by (Responsible Party): Alcon Research ( Transcend Medical, Inc. )

Study Description

Brief Summary:

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.

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

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 897 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery
• Study Start Date: September 2009
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: CyPass Micro-Stent + Cataract Surgery; Subjects 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.; Device: CyPass Micro-Stent; 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.
Active Comparator: Cataract Surgery Only; 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.

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: Baseline; Month 24 postoperative ]
   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.

Secondary Outcome Measures :

1. Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data [ Time Frame: Baseline; Month 24 postoperative ]
   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.
2. 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 [ Time Frame: Month 24 postoperative ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Preoperative Inclusion Criteria:

• Diagnosis of primary open angle glaucoma (POAG)
• Mean diurnal unmedicated IOP of 21 - 33 mmHg
• Normal anterior chamber angle anatomy at site of implantation
• Operable age-related cataract

Exclusion Criteria:

• Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
• Significant risk associated with washout of ocular hypotensive medication
• Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
• Previous corneal surgery
• Clinically significant ocular pathology, other than cataract and glaucoma
• Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma

Contacts and Locations

Sponsors and Collaborators

Transcend Medical, Inc.

Investigators

• Study Chair: Vice President of Medical Affairs; Transcend Medical, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ianchulev T, Lane S, Masis M, Lass JH, Benetz BA, Menegay HJ, Price FW, Lin S. Corneal Endothelial Cell Density and Morphology After Phacoemulsification in Patients With Primary Open-Angle Glaucoma and Cataracts: 2-Year Results of a Randomized Multicenter Trial. Cornea. 2019 Mar;38(3):325-331. doi: 10.1097/ICO.0000000000001826.

Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, Brown RH, Ianchulev T; CyPass Study Group. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts. Ophthalmology. 2016 Oct;123(10):2103-12. doi: 10.1016/j.ophtha.2016.06.032. Epub 2016 Aug 6.

Jampel HD, Chon BH, Stamper R, Packer M, Han Y, Nguyen QH, Ianchulev T. Effectiveness of intraocular pressure-lowering medication determined by washout. JAMA Ophthalmol. 2014 Apr 1;132(4):390-5. doi: 10.1001/jamaophthalmol.2013.7677.

• Responsible Party: Transcend Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01085357
• Other Study ID Numbers: TMI-09-01
• First Posted: March 11, 2010
• Results First Posted: October 20, 2016
• Last Update Posted: May 15, 2017
• Last Verified: May 2017

Keywords provided by Alcon Research ( Transcend Medical, Inc. ):

Glaucoma; Glaucoma device; Glaucoma surgery; Intraocular pressure

Additional relevant MeSH terms:

Glaucoma; Cataract; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Lens Diseases