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No Drop Post-Op Cataract Surgery

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omidria

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Omidria

Arm Description

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

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity (BCVA) (pre-op)

Best vision will be tested with lens correction using Snellen Charts.

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.

Best Corrected Visual Acuity (BCVA) (week 6)

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)

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

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.

Amount of Topical NSAID needed

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 cell and flare from baseline measurement

Anterior chamber cells and flare will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.

Secondary Outcome Measures

Full Information

NCT ID

NCT03864133

First Posted

February 13, 2019

Last Updated

September 24, 2021

Sponsor

Wake Forest University Health Sciences

Collaborators

Omeros Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03864133

Brief Title

No Drop Post-Op Cataract Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 8, 2019 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Omeros Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omidria

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omidria

Intervention Description

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

Primary Outcome Measure Information:

Title

Best Corrected Visual Acuity (BCVA) (pre-op)

Description

Best vision will be tested with lens correction using Snellen Charts.

Time Frame

Baseline

Title

Best Corrected Visual Acuity (BCVA) (week 2)

Description

Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.

Time Frame

2 weeks

Title

Best Corrected Visual Acuity (BCVA) (week 6)

Description

Best distance vision will be measured clinically to determine if improvements have been made post-operatively.

Time Frame

6 weeks

Title

Number of participants that develop Presence of Cystoid Macular Edema (CME)

Description

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

Title

Change From Baseline in Macular Thickness Measurement

Description

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.

Time Frame

Baseline, 2 weeks and 6 weeks

Title

Amount of Topical NSAID needed

Description

Time Frame

Post-op weeks 1 through 6

Title

Change in Anterior Chamber cell and flare from baseline measurement

Description

Anterior chamber cells and flare will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.

Time Frame

Post-op day 1, week 2 and week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keith Walter, MD

Organizational Affiliation

Wake Forest Baptist Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28366368

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.

Results Reference

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PubMed Identifier

26232601

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.

Results Reference

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PubMed Identifier

23321360

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.

Results Reference

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PubMed Identifier

24935281

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.

Results Reference

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PubMed Identifier

17720069

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.

Results Reference

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PubMed Identifier

18721711

Citation

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.

Results Reference

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PubMed Identifier

29227185

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.

Results Reference

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PubMed Identifier

20159228

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.

Results Reference

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PubMed Identifier

29778106

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.

Results Reference

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No Drop Post-Op Cataract Surgery

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