This study is currently not recruiting participants.

A Randomized Double-Masked Parallel-Group Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth through Three Years Undergoing Unilateral Cataract Extraction with or without Lens Replacement

Study on the Effect of an Investigational Medication on Pupil Dilation and Eye Pain During Cataract (a condition where the lens of the eye becomes cloudy) Surgery

Not Recruiting
3 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to determine if adding OMS302 (Omidria phenylephrine and ketorolac injection 1%/0.3%) to the rinsing solution helps keep the pupil dilated during surgery and to see if it reduces eye pain after surgery.

Detailed description of study

The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction with or without lens replacement (cataract extraction) on intraoperative pupil diameter, post operative pain and safety.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: cataracts
  • Age: 3 years or below
  • Gender: All

This study investigates the effect of an investigational medication on keeping the pupil dilated during cataract surgery and reducing eye pain afterward. Cataract surgery involves removing the cloudy lens of the eye and may include replacing it with an artificial lens. The study aims to compare the investigational medication with another standard medication to see how it affects pupil size during surgery and pain after surgery.

Participants will receive the investigational medication or a standard medication in the rinsing solution used during the surgery. The study will measure the pupil size during the operation and assess pain levels after the procedure to ensure the safety and effectiveness of the treatment.

  • Who can participate: Individuals aged 18 and older undergoing cataract extraction surgery, with or without lens replacement, may be eligible to participate. Specific inclusion and exclusion criteria were not provided.
  • Study details: Participants will receive either the investigational medication or a standard medication in the rinsing solution during their cataract surgery. The study will measure pupil size and assess pain levels after the procedure. If a placebo is used, it will be an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1404789308

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