Cataract
Conditions
Brief 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.
Detailed description
Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain in patients undergoing cataract surgery. Routine cataract surgery without the protection of topical NSAIDs results in an increase of the number of patients with macular edema and macular thickening. Omidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during cataract surgery to decrease post-operative pain and inflammation. It is also indicated to maintain pupil dilation during cataract surgery. This study will evaluate whether treating patients with Omidria during cataract surgery will control post-operative pain and inflammation as well as reduce or eliminate macular edema without the use of adjunctive topical NSAIDs.
Interventions
DRUGOmidria
Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Sponsors
Omeros Corporation
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) (Pre-op) | Baseline | Best vision will be tested with lens correction using Snellen Charts. |
| Best Corrected Visual Acuity (BCVA) (Week 2) | 2 weeks | Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively. |
| Best Corrected Visual Acuity (BCVA) (Week 6) | 6 weeks | Best distance vision will be measured clinically to determine if improvements have been made post-operatively. |
| Number of Participants That Develop Presence of Cystoid Macular Edema (CME) | 2 weeks | The number of participants that develop CME will be recorded to evaluate if Omidria is sufficient in controlling CME. The presence of CME will be determined clinically. |
| Change From Baseline in Macular Thickness Measurement - Number in Microns | Baseline and week 6 | The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns |
| Number of Participants Needing NSAID Post-operatively | Post-op weeks 1 through 6 | Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed. |
| Change in Anterior Chamber Cells From Baseline Measurement | Week 6 | Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery. Range and meaning (if score/scale): 0-2 0 = no cell 1. = 10-20 cells 2. = greater than 20 cells |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omidria Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.
Omidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery. | 94 |
| Total | 94 |
Baseline characteristics
| Characteristic | Omidria |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 94 |
| other Total, other adverse events | 94 / 94 |
| serious Total, serious adverse events | 1 / 94 |
Outcome results
Primary
Best Corrected Visual Acuity (BCVA) (Pre-op)
Best vision will be tested with lens correction using Snellen Charts.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omidria | Best Corrected Visual Acuity (BCVA) (Pre-op) | .28 LogMar | Standard Deviation 0.2 |
Primary
Best Corrected Visual Acuity (BCVA) (Week 2)
Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omidria | Best Corrected Visual Acuity (BCVA) (Week 2) | .18 LogMar | Standard Deviation 0.2 |
Primary
Best Corrected Visual Acuity (BCVA) (Week 6)
Best distance vision will be measured clinically to determine if improvements have been made post-operatively.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omidria | Best Corrected Visual Acuity (BCVA) (Week 6) | .11 LogMar | Standard Deviation 0.2 |
Primary
Change From Baseline in Macular Thickness Measurement - Number in Microns
The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns
Time frame: Baseline and week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omidria | Change From Baseline in Macular Thickness Measurement - Number in Microns | 12 Number of Microns | Standard Deviation 0.2 |
Primary
Change in Anterior Chamber Cells From Baseline Measurement
Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery. Range and meaning (if score/scale): 0-2 0 = no cell 1. = 10-20 cells 2. = greater than 20 cells
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omidria | Change in Anterior Chamber Cells From Baseline Measurement | .08 Cell Score - Score on a Scale | Standard Deviation 0.2 |
Primary
Number of Participants Needing NSAID Post-operatively
Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed.
Time frame: Post-op weeks 1 through 6
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omidria | Number of Participants Needing NSAID Post-operatively | Week 2 | 0 Participants |
| Omidria | Number of Participants Needing NSAID Post-operatively | Week 1 | 0 Participants |
| Omidria | Number of Participants Needing NSAID Post-operatively | Week 3 | 0 Participants |
| Omidria | Number of Participants Needing NSAID Post-operatively | Week 4 | 3 Participants |
| Omidria | Number of Participants Needing NSAID Post-operatively | Week 5 | 0 Participants |
| Omidria | Number of Participants Needing NSAID Post-operatively | Week 6 | 5 Participants |
Primary
Number of Participants That Develop Presence of Cystoid Macular Edema (CME)
The number of participants that develop CME will be recorded to evaluate if Omidria is sufficient in controlling CME. The presence of CME will be determined clinically.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omidria | Number of Participants That Develop Presence of Cystoid Macular Edema (CME) | 0 Participants |