NCT02423213

Brief Summary

Optical coherence tomography (OCT )provides high resolution information regarding the anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view. Much of this information is not able to be visualized by a clinician. Utilizing this information during surgery will allow for the ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye. In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2014Jan 2027

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 26, 2025

Status Verified

May 1, 2025

Enrollment Period

13 years

First QC Date

April 8, 2015

Last Update Submit

June 23, 2025

Conditions

Retinal DiseasesFuchs Endothelial DystrophyMacular HoleEpiretinal MembraneRetinal Detachment

Keywords

OCTimage-guided surgeryophthalmic surgery

Outcome Measures

Primary Outcomes (1)

  • To assess feasibility of microscope-integrated intraoperative OCT

    Feasibility will be assessed as the percentage of cases where OCT images were successfully obtained with a microscope-integrated system

    3 years

Secondary Outcomes (1)

  • To assess utility of microscope-integrated intraoperative OCT on surgical decision-making

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes any patient requiring ophthalmic surgery who meets the inclusion criteria for feasibility of OCT imaging.

You may qualify if:

  • The study population includes any patient requiring ophthalmic surgery

You may not qualify if:

  • Under the age of 18 years.
  • Cognitive/Mentally impaired or unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (2)

  • Ehlers JP, Srivastava SK, Feiler D, Noonan AI, Rollins AM, Tao YK. Integrative advances for OCT-guided ophthalmic surgery and intraoperative OCT: microscope integration, surgical instrumentation, and heads-up display surgeon feedback. PLoS One. 2014 Aug 20;9(8):e105224. doi: 10.1371/journal.pone.0105224. eCollection 2014.

    PMID: 25141340BACKGROUND

  • Ehlers JP, Kaiser PK, Srivastava SK. Intraoperative optical coherence tomography using the RESCAN 700: preliminary results from the DISCOVER study. Br J Ophthalmol. 2014 Oct;98(10):1329-32. doi: 10.1136/bjophthalmol-2014-305294. Epub 2014 Apr 29.

    PMID: 24782469BACKGROUND

MeSH Terms

Conditions

Retinal DiseasesFuchs' Endothelial DystrophyRetinal PerforationsEpiretinal MembraneRetinal Detachment

Condition Hierarchy (Ancestors)

Eye DiseasesCorneal Dystrophies, HereditaryCorneal DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Justis P Ehlers, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justis P Ehlers, M.D.

CONTACT

216-636-0183ehlersj@ccf.org

Jamie L Reese, R.N.

CONTACT

216-636-0183reesej3@ccf.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 22, 2015

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)