CompletedPhase 4

Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients

United States22 participantsStarted 2020-11-10

Plain-language summary

Steep Trendelenburg positioning and insufflation of the abdominal cavity have shown to increase intra ocular pressure. Different anesthetic techniques can alter intra ocular pressure and a small pilot study showed decrease in Intraocular Pressure (IOP) in robotic case in steep Trendelenburg with IV anesthetics (TIVA). We want to quantify the degree of change in Intraocular Pressure (IOP) in female patients undergoing robotic procedures for cancer. We want to detect the difference in increase of pressure with total IV anesthesia versus conventional balanced anesthesia

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

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: * Females ≥ eighteen years of age * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures * Subjects must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer) * Subjects must be cleared for surgery by the pre-anesthesia clinic * All robotic GYN cancer patients 18 years of age and older with any preexisting medical conditions that are deemed ready for surgery by the pre anesthesia clinic Exclusion Criteria: * Known increased intraocular pressure, prior eye surgery within a month, eye conditions where the ophthalmologist would not allow an intra ocular pressure measurement * Subjects with a previous treatment of diagnosis of increased intraocular pressure * Subjects who have undergone eye surgery in the 30 days prior to consent * Subjects for whom an ophthalmologist has determined cannot undergo intraocular pressure measurement

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

Quantify the Degree of Change in Intra Ocular Pressure in Female Patients Undergoing Robotic Procedures

Timeframe: Day of Surgery

Trial details

NCT IDNCT04281017

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-20

Results submitted2026-06-25

View on ClinicalTrials.gov More Intraocular Pressure trials