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CataractPhase 4NCT03864133

No Drop Post-Op Cataract Surgery

A Phase 4 study testing Omidria in people with Cataract, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Cataract
What is being tested?
Omidria
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteUnited States
Study dates
8 Jul 2019to 16 Aug 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Cataract
Being tested
Omidria
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmidriaDrug

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

Study groups in NCT03864133
Study groupRoleWhat they receive
OmidriaOtherPhenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.
Receives: Drug: Omidria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Corrected Visual Acuity (BCVA) (Pre-op)

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

    Measured: Baseline

  2. 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.

    Measured: 2 weeks

  3. Best Corrected Visual Acuity (BCVA) (Week 6)

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

    Measured: 6 weeks

  4. 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.

    Measured: 2 weeks

  5. 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

    Measured: Baseline and week 6

  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.

    Measured: Post-op weeks 1 through 6

  7. 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

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start8 Jul 2019
  3. Primary completion30 Jun 2021
  4. Study completion16 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03864133
Sponsor's protocol ID
IRB00050415
Status last verified
Jun 2021
First submitted
13 Feb 2019
Last updated
30 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28366368

  • 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.

    PubMed 26232601

  • 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.

    PubMed 23321360

  • 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.

    PubMed 24935281

  • 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.

    PubMed 17720069

  • 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.

    PubMed 18721711

  • 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.

    PubMed 29227185

  • 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.

    PubMed 20159228

  • 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.

    PubMed 29778106

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omidria in people with Cataract, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Corrected Visual Acuity (BCVA) (Pre-op) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03864133, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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No Drop Post-Op Cataract Surgery (NCT03864133) | AzTrials