No Drop Post-Op Cataract Surgery

Cataract Clinical Trial

Official title:

The Effects of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864133
• Other study ID #: IRB00050415
• Status: Completed
• Phase: Phase 4
• Start date: July 8, 2019
• Est. completion date: August 16, 2021

Study information

• Verified date: June 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 16, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Omidria
Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Omeros Corporation

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Cataract Refract Surg. 2018 Sep;44(9):1166. — View Citation

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. Erratum In: J Cataract Refract Surg. 2017 Aug;43(8):1126. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (BCVA) (Pre-op)	Best vision will be tested with lens correction using Snellen Charts.	Baseline
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.	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.	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.	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	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.	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; = 10-20 cells; = greater than 20 cells	Week 6