RECRUITING

Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.

Official Title

Prospective Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative Standard of Care

Quick Facts

Study Start:2024-07-10

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06681688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult participants \> 18 years of age undergoing bilateral cataract surgery * Able to provide written informed consent prior to any study related procedure * Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study * Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months * Participants who do not meet the exclusion criteria may be enrolled.	* Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.) * Glaucoma patients or known steroid responders * Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.) * Intraocular injection within 6 months * Any prior ocular implant * Diagnosis of retinal thickening in the study eye within 12 months of enrollment * Inability to provide informed consent * Participation in another clinical trial

Inclusion Criteria

Exclusion Criteria

* Adult participants \> 18 years of age undergoing bilateral cataract surgery
* Able to provide written informed consent prior to any study related procedure
* Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
* Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months
* Participants who do not meet the exclusion criteria may be enrolled.

* Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
* Glaucoma patients or known steroid responders
* Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
* Intraocular injection within 6 months
* Any prior ocular implant
* Diagnosis of retinal thickening in the study eye within 12 months of enrollment
* Inability to provide informed consent
* Participation in another clinical trial

Contacts and Locations

Study Contact

Paul Singh, MD

CONTACT

262-637-0500

ipsingh@amazingeye.com

Cathleen McCabe, MD

CONTACT

941-493-3763

mccabe131@hotmail.com

Principal Investigator

Paul Singh, MD

PRINCIPAL_INVESTIGATOR

The Eye Centers of Racine & Kenosha

Study Locations (Sites)

The Eye Associates - Venice

Venice, Florida, 34292

United States

The Eye Centers of Racine & Kenosha

Racine, Wisconsin, 53405

United States

Collaborators and Investigators

Sponsor: Inder Paul Singh, M.D.

Paul Singh, MD, PRINCIPAL_INVESTIGATOR, The Eye Centers of Racine & Kenosha

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-07-10

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

OMIDRIA

Additional Relevant MeSH Terms

Cataract