Comparision of Retinal Surgery by Three-dimensional Heads-up Display to the Standard Operating Microscope

NCT03075852 | Completed FDA Device

• 1 other identifier: 17-609E
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Comparison of 3D Visualization and Microscope for VR Surgery

Keywords

Heads-up display, NGENUITY, Vitreoretinal surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative complications

  Intraoperative complications including: increased surgical time, needing to switch to standard operating microscope, increased time for ILM/ ELM peeling

  day of surgery

Secondary Outcomes (1)

• Visual Acuity

  baseline and 3 months

Other Outcomes (2)

• Intraoperative time

  day of surgery

• Ease of use score

  day of surgery

Study Arms (2)

3D VRS Patients

Those who undergo surgery with NGENUITY (3D VRS-Vitreoretinal surgery)

Device: Heads- Up Display Surgery

Standard operating microscope

Those who undergo surgery with the standard operating microscope

Interventions

Heads- Up Display Surgery DEVICE

Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon.

Also known as: NGENUITY surgical display system

3D VRS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Those age 18 or older undergoing vitreoretinal surgery from the Mid Altantic Retina, Wills Eye location office, 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

You may qualify if:

• Eligible patients are those age 18 or older 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

You may not qualify if:

• Prisoners, institutionalized patients, and those who have undergone previous pars plana vitrectomy will be excluded. Patients undergoing combined, simultaneous scleral buckle placement and pars plana vitrectomy will also be excluded

Sponsors & Collaborators

• MidAtlantic Retina: lead
• Alcon Research: collaborator

Study Sites (1)

MidAtlantic Retina-Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Eckardt C, Paulo EB. HEADS-UP SURGERY FOR VITREORETINAL PROCEDURES: An Experimental and Clinical Study. Retina. 2016 Jan;36(1):137-47. doi: 10.1097/IAE.0000000000000689.

  PMID: 26200516 BACKGROUND

Study Officials

• Allen C Ho, MD

  Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: May 26, 2017
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)