Clinical trial NCT00774228: I-ZIP Ocular Bandage Pivotal Study
Official title: Clinical Evaluation of the I-ZIP® Ocular Bandage as a Protective Ocular Bandage in Subjects Undergoing Clear Corneal Cataract Surgery With IOL Implantation: A Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract or intraocular lens placement surgery
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain or discomfort in the acute post-operative period.


Eligibility criteria: Inclusion Criteria:

* Subject has a cataract and is expected to undergo unilateral clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber monofocal intraocular lens through an incision ≤ 3.5mm in width measured after IOL implantation using internal calipers.

Exclusion Criteria:

* Any intraocular inflammation in the study eye that was present during the screening slit-lamp examination or presence of ocular pain in the operative eye as rated on the pre-operative NRPS
* Previous surgery (laser or incisional) or ocular trauma to the operative eye or planned multiple procedures during cataract/IOL implantation surgery
* Potential BCVA in fellow eye worse than 20/40 as assessed by the clinical Investigator
* Active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically significant dry eye syndrome, anything more than trace guttata (\>10 guttae in the central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or other ocular disease that would interfere with study evaluations
* Subject is currently receiving antineoplastic therapy
* Use of topical ocular steroids within 14 days and/or systemic steroids (excluding inhalants) within 30 days prior to surgery.
* Subject is an insulin-dependent diabetic or has background diabetic retinopathy (BDR), proliferative diabetic retinopathy (PDR) or compromised macular function

Primary outcomes:
measure: Device remains localized over corneal incision
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Adverse ocular events
timeFrame: 30 days post operative
Other outcomes:
Locations:
city: Waltham
country: United States
facility: I-Therapeutix, Inc.
state: Massachusetts
Study officials:
References:
citation: Dell SJ, Hovanesian JA, Raizman MB, Crandall AS, Doane J, Snyder M, Masket S, Lane S, Fram N; Ocular Bandage Study Group. Randomized comparison of postoperative use of hydrogel ocular bandage and collagen corneal shield for wound protection and patient tolerability after cataract surgery. J Cataract Refract Surg. 2011 Jan;37(1):113-21. doi: 10.1016/j.jcrs.2010.11.001.