CompletedPhase 3

A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

United States78 participantsStarted 2014-07

Plain-language summary

The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.

Who can participate

Age range

1 Day – 47 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Are 0 through three years of age at the time of surgery.
. Are to undergo unilateral primary cataract extraction with or without lens replacement.
. Have informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization provided by a parent or legal guardian in accordance with local regulations and governing IRB/IEC requirements prior to any procedures or evaluations performed specifically for the sole purpose of this study.
. A parent or legal guardian has indicated that they understand and are able, willing, and likely to fully comply with study procedures and restrictions.

Exclusion criteria

. Corneal diameter less than nine millimeters in the study eye.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative Pupil Diameter

Timeframe: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure), the mean time of surgery duration is 35.46 minutes with a standard deviation of 19.98.

Acute Postoperative Pain

Timeframe: 24 hours

Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.

Timeframe: 90 days

Trial details

NCT IDNCT02132312

SponsorOmeros Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-12

Results submitted2021-01-27

View on ClinicalTrials.gov More Unilateral Cataract Extraction trials