Clinical trial NCT01085357: Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Cataract
Keywords: Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 897
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline; Month 24 postoperative
Secondary outcomes:
measure: Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data
timeFrame: Baseline; Month 24 postoperative
measure: 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
timeFrame: Month 24 postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Transcend Medical, Inc.
name: Vice President of Medical Affairs
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.