Phase 4
N=94
No Drop Post-Op Cataract Surgery
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT03864133 ↗Enrolled (actual)
94
Serious AEs
1.1%
Results posted
Nov 2023
Primary outcome: Primary: Best Corrected Visual Acuity (BCVA) (Pre-op) — .28 LogMar
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omidria (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Visual Acuity (BCVA) (Pre-op) |
.28 | — |
| PRIMARY Best Corrected Visual Acuity (BCVA) (Week 2) |
.18 | — |
| PRIMARY Best Corrected Visual Acuity (BCVA) (Week 6) |
.11 | — |
| PRIMARY Number of Participants That Develop Presence of Cystoid Macular Edema (CME) |
— | — |
| PRIMARY Change From Baseline in Macular Thickness Measurement - Number in Microns |
12 | — |
| PRIMARY Number of Participants Needing NSAID Post-operatively |
0; 0; 0; 3; 0; 5 | — |
| PRIMARY Change in Anterior Chamber Cells From Baseline Measurement |
.08 | — |
Summary
This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.
Eligibility Criteria
Inclusion Criteria
- Adults age 55-90 years with visual significant cataracts in one or both eyes.
- Healthy individuals able to tolerate outpatient cataract surgery under local anesthesia via either phacoemulsification and/or femtosecond assisted cataract surgery. Well-controlled diabetes, hypertension will be included.
- Females of childbearing potential must agree to use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days from the last normal menstrual period, if the patient is a sexually active female of childbearing potential.
Exclusion Criteria
- Allergy to Phenylephrine or NSAIDs.
- Inability to sit steady and upright for the Optical Coherence Tomography (OCT).
- Complications during surgery, including posterior capsular rupture, vitreous loss, zonular dialysis, or iris trauma.
- Macular thickness above 300 microns at baseline
- Currently taking a prostaglandin analogue
- Presence of an epiretinal membrane on the preoperative OCT.
- Retained lens fragment post-operatively.
- Inability to return for follow appointments
- Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.
Data sourced from ClinicalTrials.gov (NCT03864133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.