Cataract Surgery Incision Leak Clinical Trial
Official title:
ReSure Sealant Pivotal Study
| Verified date | February 2016 |
| Source | Ocular Therapeutix, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.
| Status | Completed |
| Enrollment | 488 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 22 Years and older |
| Eligibility |
Inclusion Criteria: - Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens - Subject must be 22 years of age or older Exclusion Criteria: - Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment - Previous corneal or retinal surgery or planned multiple procedures during cataract surgery. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Levenson Eye Associates | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Ocular Therapeutix, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Presence of ReSure Sealant or suture(s) | Presence of ReSure Sealant or suture(s)at every follow-up visit | Day 28 | Yes |
| Other | Presence of blue colorant in ReSure Sealant | Presence of blue colorant in ReSure Sealant at every follow-up visit | Day 28 | Yes |
| Other | Device ease of use | Device ease of use during application | Day 0 | No |
| Other | Corneal edema at 1 day | Corneal edema at 1 day (moderate to severe stromal edema) | Day 1 | Yes |
| Other | Anterior chamber inflammation | Anterior chamber inflammation (defined as greater than or equal to grade 2+ anterior chamber cells) at day 1 | Day 1 | Yes |
| Primary | Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery. | Days 1-28 | Yes | |
| Secondary | Foreign Body Sensation | Days 1-28 | Yes | |
| Secondary | Best corrected visual acuity | Best corrected visual acuity worse than 20/40 at day 1 | Day 1 | No |
| Secondary | Best corrected visual acuity | Best corrected visual acuity worse than 20/40 at 28 days | Day 28 | No |