Cataract Surgery Incision Leak
Conditions
Keywords
Cataract surgery
Brief summary
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.
Interventions
DEVICEReSure Sealant
Comparison of ReSure Sealant to suture(s)
PROCEDURESutures
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foreign Body Sensation | Days 1-28 | — |
| Best corrected visual acuity | Day 1 | Best corrected visual acuity worse than 20/40 at day 1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Corneal edema at 1 day | Day 1 | Corneal edema at 1 day (moderate to severe stromal edema) |
| Presence of ReSure Sealant or suture(s) | Day 28 | Presence of ReSure Sealant or suture(s)at every follow-up visit |
| Anterior chamber inflammation | Day 1 | Anterior chamber inflammation (defined as greater than or equal to grade 2+ anterior chamber cells) at day 1 |
| Presence of blue colorant in ReSure Sealant | Day 28 | Presence of blue colorant in ReSure Sealant at every follow-up visit |
| Device ease of use | Day 0 | Device ease of use during application |
Countries
United States
Outcome results
None listed