Influence of Intraoperative Trendelenburg Positioning and Pneumoperitoneum on Visual Function

Investigating Surgical Positions and Their Impact on Vision in Idiopathic Intracranial Hypertension

D
Devon Mackay

Primary Investigator

Enrolling By Invitation
17 years or below
All
Phase N/A
10 participants needed
1 Location

Brief description of study

What is the purpose of this study?

This study is being done because we want to find out whether certain surgical positions, like Trendelenburg positioning (TP) or pneumoperitoneum (PP), could make optic nerve swelling (papilledema) or vision problems worse in people with idiopathic intracranial hypertension (IIH).

THIS STUDY IS ENROLLING BY INVITATION ONLY - All patients will be referred from IU Health Urology, OB/GYN, Neurosurgery and Plastic Surgery departments. 

Detailed description of study

What will happen during the study?

Testing that will be performed by  IUH Ophthalmology staff or technicians at the primary study location (IU Neuroscience Center, Suite 3200, 355 W 15th St, Indianapolis, IN 46202). Parking at the Neuroscience Center is a nominal amount (approximately $5) that will be compensated for by study staff.

Testing includes (in both eyes):
-    Optical Coherence Tomography (OCT) of the retinal nerve fiber layer (RNFL)
-    OCT of the ganglion cell complex (GCC) 
-    OCT of the macula
-    Fundus photography
-    Snellen Visual acuity at distance
-    Pupil examination

The study participant will need to be able and willing to take part in the above testing which will involve approximately 10 minutes of total procedure time, and 5-10 minutes of navigating into the testing area, waiting for technician availability, etc. 

Eligibility of study

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

  • Conditions: Idiopathic Intracranial Hypertension, IIH
  • Age: 17 years or below
  • Gender: All

Inclusion Criteria
•    Patients with Idiopathic Intracranial Hypertension (IIH) diagnosed by Modified Dandy Criteria
•    Undergoing urologic or gynecologic surgery involving TP of at least 20 degrees declination and/or pneumoperitoneum insufflation of at least 12mmHg for any length of time
•    Patients must have true papilledema documented by previous optometrist, Ophthalmologist, or Neuro-ophthalmologist

Exclusion Criteria
•    Patients with optic disc edema from any etiology other than IIH
•    Unable to attend preoperative and postoperative visit 

Updated on 30 Jun 2025. Study ID: NEUR-IIR-ITP-PVF, 26650

This study investigates how certain surgical positions, such as Trendelenburg positioning (TP) and pneumoperitoneum (PP), might affect the optic nerve and vision in people with idiopathic intracranial hypertension (IIH). Idiopathic intracranial hypertension is a condition where the pressure around the brain increases, which can lead to optic nerve swelling known as papilledema, and vision problems. The study aims to understand if these surgical practices worsen these symptoms.

During the study, participants will undergo several eye tests performed by IUH Ophthalmology staff at the IU Neuroscience Center. These tests include Optical Coherence Tomography (OCT) of the retinal nerve fiber layer, ganglion cell complex, macula, fundus photography, Snellen visual acuity tests, and pupil examinations. These procedures will take approximately 10 minutes, with additional time for preparation and waiting.

  • Who can participate: Participants must have idiopathic intracranial hypertension diagnosed by the Modified Dandy Criteria and be undergoing urologic or gynecologic surgery involving specific surgical positions. They must also have documented papilledema.
  • Study details: Participants will undergo a series of eye examinations to assess the impact of surgical positions on their vision. These tests are non-invasive and involve imaging and visual acuity assessments.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only