NCT06681688 Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC
| NCT ID | NCT06681688 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Inder Paul Singh, M.D. |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 94 participants in total. It began in 2024-07-10 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.) * Glaucoma patients or known steroid responders * Oral anti-inflammatory
Frequently Asked Questions
Who can join the NCT06681688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06681688 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06681688 currently recruiting?
Yes, NCT06681688 is actively recruiting participants. Visit ClinicalTrials.gov or contact Inder Paul Singh, M.D. to inquire about joining.
Where is the NCT06681688 trial being conducted?
This trial is being conducted at Venice, United States, Racine, United States.
Who is sponsoring the NCT06681688 clinical trial?
NCT06681688 is sponsored by Inder Paul Singh, M.D.. The trial plans to enroll 94 participants.