No Drop Post-Op Cataract Surgery

NCT03864133 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00050415
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (7)

• 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

• 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

  Week 6

Study Arms (1)

Omidria

OTHER

Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.

Drug: Omidria

Interventions

Omidria DRUG

Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.

Omidria

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Omeros Corporation: collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (9)

• 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.

  PMID: 28366368 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.

  PMID: 26232601 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.

  PMID: 23321360 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.

  PMID: 24935281 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.

  PMID: 17720069 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.

  PMID: 18721711 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.

  PMID: 29227185 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.

  PMID: 20159228 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.

  PMID: 29778106 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Keith Walter, MD
• Organization: Wake Forest University Health Sciences

kwalter@wakehealth.edu

336-716-3937

Study Officials

• Keith Walter, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: March 6, 2019
• Study Start: July 8, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 16, 2021
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)