NCT02423161

Brief Summary

OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
8 months 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
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

April 8, 2015

Last Update Submit

August 19, 2024

Conditions

Retinal DetachmentEpiretinal MembraneMacular HoleFuchs Endothelial Dystrophy

Keywords

OCTimage-guided surgeryvitreoretinal surgerycorneal surgery

Outcome Measures

Primary Outcomes (1)

  • Feasibility of intraoperative OCT

    Defined as percentage of cases where OCT was successfully able to be obtained during surgery

    3 years

Secondary Outcomes (3)

  • Utility of intraoperative OCT

    3 years

  • Safety of intraoperative OCT

    3 years

  • Time requirements for intraoperative OCT

    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

You may qualify if:

  • The study population includes any patient requiring ophthalmic surgery

You may not qualify if:

  • Children under the age of 18
  • Cognitive/Mentally impaired or unable to provide consent
  • Media opacity precluding OCT scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

  • Ehlers JP, Ohr MP, Kaiser PK, Srivastava SK. Novel microarchitectural dynamics in rhegmatogenous retinal detachments identified with intraoperative optical coherence tomography. Retina. 2013 Jul-Aug;33(7):1428-34. doi: 10.1097/IAE.0b013e31828396b7.

    PMID: 23609120BACKGROUND

  • Ehlers JP, Xu D, Kaiser PK, Singh RP, Srivastava SK. Intrasurgical dynamics of macular hole surgery: an assessment of surgery-induced ultrastructural alterations with intraoperative optical coherence tomography. Retina. 2014 Feb;34(2):213-21. doi: 10.1097/IAE.0b013e318297daf3.

    PMID: 23860560BACKGROUND

  • Ehlers JP, Itoh Y, Xu LT, Kaiser PK, Singh RP, Srivastava SK. Factors associated with persistent subfoveal fluid and complete macular hole closure in the PIONEER study. Invest Ophthalmol Vis Sci. 2014 Dec 18;56(2):1141-6. doi: 10.1167/iovs.14-15765.

    PMID: 25525173RESULT

  • Ehlers JP, Dupps WJ, Kaiser PK, Goshe J, Singh RP, Petkovsek D, Srivastava SK. The Prospective Intraoperative and Perioperative Ophthalmic ImagiNg with Optical CoherEncE TomogRaphy (PIONEER) Study: 2-year results. Am J Ophthalmol. 2014 Nov;158(5):999-1007. doi: 10.1016/j.ajo.2014.07.034. Epub 2014 Jul 29.

    PMID: 25077834RESULT

  • Juthani VV, Goshe JM, Srivastava SK, Ehlers JP. Association between transient interface fluid on intraoperative OCT and textural interface opacity after DSAEK surgery in the PIONEER study. Cornea. 2014 Sep;33(9):887-92. doi: 10.1097/ICO.0000000000000209.

    PMID: 25055146RESULT

  • Au J, Goshe J, Dupps WJ Jr, Srivastava SK, Ehlers JP. Intraoperative Optical Coherence Tomography for Enhanced Depth Visualization in Deep Anterior Lamellar Keratoplasty From the PIONEER Study. Cornea. 2015 Sep;34(9):1039-43. doi: 10.1097/ICO.0000000000000508.

    PMID: 26114817DERIVED

MeSH Terms

Conditions

Retinal DetachmentEpiretinal MembraneRetinal PerforationsFuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Justis P Ehlers, MD

    Cole Eye Institute, Cleveland Clinic, OH 44195

    PRINCIPAL INVESTIGATOR

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

August 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2017

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations

US(1)