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| Name | Class |
|---|---|
| Omeros Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omidria | Other | Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omidria | Drug | Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) (Pre-op) | Best vision will be tested with lens correction using Snellen Charts. | Baseline |
| 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. | 2 weeks |
| Best Corrected Visual Acuity (BCVA) (Week 6) | Best distance vision will be measured clinically to determine if improvements have been made post-operatively. | 6 weeks |
| 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. | 2 weeks |
| 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 | Baseline and week 6 |
| 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. | Post-op weeks 1 through 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Walter, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28366368 | Background | Yang J, Cai L, Sun Z, Ye H, Fan Q, Zhang K, Lu W, Lu Y. Risk factors for and diagnosis of pseudophakic cystoid macular edema after cataract surgery in diabetic patients. J Cataract Refract Surg. 2017 Feb;43(2):207-214. doi: 10.1016/j.jcrs.2016.11.047. | |
| 26232601 | Background | Wielders LH, Lambermont VA, Schouten JS, van den Biggelaar FJ, Worthy G, Simons RW, Winkens B, Nuijts RM. Prevention of Cystoid Macular Edema After Cataract Surgery in Nondiabetic and Diabetic Patients: A Systematic Review and Meta-Analysis. Am J Ophthalmol. 2015 Nov;160(5):968-981.e33. doi: 10.1016/j.ajo.2015.07.032. Epub 2015 Jul 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Corrected Visual Acuity (BCVA) (Pre-op) | Best vision will be tested with lens correction using Snellen Charts. | Posted | Mean | Standard Deviation | LogMar | Baseline |
|
|
Week 6
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blindness | Eye disorders | Non-systematic Assessment | Blindness |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| photophobia | Eye disorders | Non-systematic Assessment | abnormal sensitivity to light, especially of the eyes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Walter, MD | Wake Forest University Health Sciences | 336-716-3937 | kwalter@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2019 | Oct 12, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2020 | Sep 24, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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
| Week 6 |
| 23321360 | Background | Novack GD. Quality of generic ophthalmic drugs. Ocul Surf. 2013 Jan;11(1):54-6. doi: 10.1016/j.jtos.2012.10.002. Epub 2012 Oct 17. No abstract available. |
| 24935281 | Background | Kessel L, Tendal B, Jorgensen KJ, Erngaard D, Flesner P, Andresen JL, Hjortdal J. Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology. 2014 Oct;121(10):1915-24. doi: 10.1016/j.ophtha.2014.04.035. Epub 2014 Jun 14. |
| 17720069 | Background | Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550-8. doi: 10.1016/j.jcrs.2007.05.013. |
| 18721711 | Background | Bucci FA Jr, Waterbury LD. Comparison of ketorolac 0.4% and bromfenac 0.09% at trough dosing: aqueous drug absorption and prostaglandin E2 levels. J Cataract Refract Surg. 2008 Sep;34(9):1509-12. doi: 10.1016/j.jcrs.2008.05.023. |
| 29227185 | Background | Waterbury LD. Alternative Drug Delivery for Patients Undergoing Cataract Surgery as Demonstrated in a Canine Model. J Ocul Pharmacol Ther. 2018 Jan/Feb;34(1-2):154-160. doi: 10.1089/jop.2017.0048. Epub 2017 Dec 11. |
| 20159228 | Background | Kim SJ, Flach AJ, Jampol LM. Nonsteroidal anti-inflammatory drugs in ophthalmology. Surv Ophthalmol. 2010 Mar-Apr;55(2):108-33. doi: 10.1016/j.survophthal.2009.07.005. |
| 29778106 | Background | Wielders LHP, Schouten JSAG, Winkens B, van den Biggelaar FJHM, Veldhuizen CA, Findl O, Murta JCN, Goslings WRO, Tassignon MJ, Joosse MV, Henry YP, Rulo AHF, Guell JL, Amon M, Kohnen T, Nuijts RMMA; ESCRS PREMED Study Group. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 Apr;44(4):429-439. doi: 10.1016/j.jcrs.2018.01.029. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | LogMar | 2 weeks |
|
|
|
| Primary | Best Corrected Visual Acuity (BCVA) (Week 6) | Best distance vision will be measured clinically to determine if improvements have been made post-operatively. | Posted | Mean | Standard Deviation | LogMar | 6 weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Number of Microns | Baseline and week 6 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Post-op weeks 1 through 6 |
|
|
|
| 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
| Posted | Mean | Standard Deviation | Cell Score - Score on a Scale | Week 6 |
|
|
|
| 0 |
| 94 |
| 1 |
| 94 |
| 94 |
| 94 |
|
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| Title | Measurements |
|---|
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| Week 4 |
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| Week 5 |
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| Week 6 |
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