Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03075852 |
Other study ID # |
17-609E |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 26, 2017 |
Est. completion date |
August 8, 2018 |
Study information
Verified date |
August 2018 |
Source |
Wills Eye |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Prospective, cross-sectional, observational study investigating a three dimensional heads up
display for retinal surgery and comparing its outcomes and ease of use with the standard
operative microscope.
Description:
Prospective, cross-sectional, observational study. Patient are undergoing vitreoretinal
surgery for a variety of indications including, but not limited to, epiretinal membrane
(ERM), macular hole, vitreous opacities, vitreous hemorrhage, aphakia, dislocated or
displaced intraocular or crystalline lens, rhegmatogenous retinal detachment, and tractional
retinal detachment. In this prospective, single-center, unmasked cross-sectional,
observational case series, at minimum of 100 consecutive eyes will undergo 23-, 25-, or
27-gauge 3-port pars plana vitrectomy (PPV) with the Constellation Vision System (Alcon
Laboratories, Hünenberg, Switzerland) using either the NGENUITY 3D HUD surgery platform or
standard operating microscope (OPMI Lumera 700 surgical microscope with ReSight (Carl Zeiss
AG, Gena, Germany), with 1:1 randomization. Surgical gauge will be dictated by operating
surgeon preference. Informed consent will be obtained from all patients enrolled in
accordance with the Declaration of Helsinki and all applicable HIPPA regulations. All
surgeries will be digitally recorded (as is routinely done for educational purposes) and
video data will be stored on password-protected, encrypted external hard-disk drives. These
drives will be stored in a secure, locked cabinet in the Research Department of the Retina
Service when not in use. All surgeries will be performed by 2 surgeons (AH and JH). Those
randomized to 3D HUD surgery will undergo PPV with a 3D high dynamic range camera (ICM5),
specialized image processing software (Version 9.5.4; TrueWare, Santa Barbara, CA), and a 46"
high-definition (1980x1024 pixel) liquid crystal display (GD-463D10, Yokohama, Japan). During
surgery with the 3D HUD, the surgeon will wear passive 3-D polarized glasses and will be
positioned approximately 1.5 m from the display. Iris aperture and image gain will be
standardized and unchanged for all cases performed with the 3D HUD. Enrolled patients will be
monitored at post-operative day 1, week 1, month 1, and month 3 to measure visual acuity,
undergo optical coherence tomography (OCT) if clinically indicated, and further examination
to document anterior segment and dilated funduscopic examination findings. Patients
undergoing epiretinal membrane (ERM) and internal limiting membrane (ILM) removal for either
macular pucker or macular hole repair will be subjected to a disease-specific surgical
protocol to examine potential differences in macular surgery between 3D HUD and traditional
microscope visualization. These patients will undergo 25-gauge 3-port PPV with 1:1
randomization to either visualization with the 3D HUD or standard operating microscope.
Indocyanine green (ICG) vital dye (**% solution) will be injected in 0.1 cc aliquots to stain
the ILM with the infusion cannula clamped and 60 seconds allowed for the dye to stain the
ILM. Endoillumination levels will initially be set to 1% and will be increased by 1%
intervals until the operating surgeon notes enough illumination to proceed with ERM/ILM
peeling. ILM peeling will be performed to the boundaries of the retinal vascular arcades and
the duration of membrane peeling will be documented. If the operating surgeon requests
increased endoilluminaton power during membrane peeling, the increased value will be
recorded. The number of macular hemorrhages and contusions induced by direct forcep trauma as
well as iatrogenic retinal breaks sustained during membrane peeling will also be recorded.
Data Collection Demographic data, diagnosis, clinical presentation, and history will be
recorded for each patient on initial examination as is done in the course of routine care.
Data elements will include age, race, date of birth, date of evaluation, medical record
number, chief complaint, past ocular history, past medical history, visual acuity, anterior
segment exam findings (i.e. ocular surface disease, lens status, etc.), funduscopic exams,
preoperative imaging and testing (OCT, FAF, Fundus Photography). Intraoperative
endoillumination levels will be recorded. Recorded surgical video files and follow-up status
will be compiled for each patient and various metrics will be recorded including total
operative time, time of ILM/ERM peeling, number of ICG aliquots required to visualize the
ILM, and intraoperative complications. Baseline and follow up data will also include visual
acuity, anterior segment and funduscopic examination, and OCT data if applicable. Other data
collected will include subjective physician surveys on the use of the two visualization
systems, including quality of visualization on a 10-point scale, perceived subjective
difficulties with vitreoretinal visualization, and overall ergonomic comfort on a 10-point
scale. Human Subjects and Informed Consent The tenets of the Declaration of Helsinki will be
followed and written informed consent obtained at the time of patient enrollment. Patients
will also be provided with a lay explanation of the study goals and protocol. The decision to
enroll in the study is entirely elective and patients will not be reimbursed for their
participation. The PHI and privacy of subjects will be maintained by strict adherence to
HIPPA and Wills Eye Institute policies. The aforementioned data will be stored prospectively
as patients are enrolled. All data upon collection will be coded and de-identified. Codes
will be created for each consecutive patient via a random number generator. All data will be
stored on a computer stored and ecrypted hard drives within an ecrypted password protected
Microsoft Excel file only accessible to members of the study team. De-identified data will be
linked to medical record numbers and date of birth. No other patient identifiers will be
recorded