I-ZIP Ocular Bandage Pivotal Study

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774228
• Other study ID #: ITX-08-002
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2021
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• I-ZIP Ocular Bandage

• Oasis 24 Hour Soft Shield Collagen Corneal Shield

Locations

Country	Name	City	State
United States	I-Therapeutix, Inc.	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device remains localized over corneal incision		24 hours post operative
Secondary	Adverse ocular events		30 days post operative