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

NCT01085357 | Completed Results DMC

• 1 other identifier: TMI-09-01
• Study Type: interventional
• Target: 897
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Open Angle Glaucoma (POAG); Cataract

Keywords

Glaucoma; Glaucoma device; Glaucoma surgery; Intraocular pressure

Outcome Measures

Primary Outcomes (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

  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.

  Baseline; Month 24 postoperative

Secondary Outcomes (2)

• Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data

  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

  Month 24 postoperative

Study Arms (2)

CyPass Micro-Stent + Cataract Surgery

EXPERIMENTAL

Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery

Procedure: Cataract Surgery; Device: CyPass Micro-Stent

Cataract Surgery Only

ACTIVE COMPARATOR

Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery

Procedure: Cataract Surgery

Interventions

Cataract Surgery PROCEDURE

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.

Cataract Surgery Only; CyPass Micro-Stent + Cataract Surgery

CyPass Micro-Stent DEVICE

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.

CyPass Micro-Stent + Cataract Surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Transcend Medical, Inc.: lead

Related Publications (3)

• 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.

  PMID: 30614901 DERIVED

• 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.

  PMID: 27506486 DERIVED

• 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.

  PMID: 24481483 DERIVED

Related Links

• Glaucoma Basics and Frequently Asked Questions
• COMPASS Clinical Study Information Website

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Glaucoma

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Vice President of Medical Affairs
• Organization: Transcend Medical, Inc.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Vice President of Medical Affairs

  Transcend Medical, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 11, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 15, 2017
• Results First Posted: October 20, 2016

Record last verified: 2017-05