PIONEER: Intraoperative and Perioperative OCT Study

Retinal Detachment Clinical Trial

— PIONEER  

Official title:

Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423161
• Other study ID #: 11-787
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: January 23, 2018
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Over the last decade, optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT has become to function as a light biopsy, allowing clinicians to visualize subtle pathologic changes in the tissue, such as macular edema or subretinal fluid. The use of OCT in the clinic setting has become the standard for monitoring diseases such as macular degeneration and diabetic retinopathy. It has quickly become the most frequent ordered diagnostic test in ophthalmology.

Due to restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-top models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retina in diseases such as retinal detachment, macular hole, and optic pit, that were not previously known. Using OCT during lamellar corneal transplant procedures, anterior segment surgeons have been able to image proper placement of the graft that was previously unattainable with a standard surgical microscopic view.

Using information gained from OCT, surgeons may be able to improve surgical decision making and improve clinical outcomes. For this study, subjects undergoing ophthalmic surgery, including vitreoretinal surgery and anterior segment surgery, would have OCT imaging performed in the perioperative period, intraoperative period, or both to document architectural changes in the ocular tissues. This information would be prospectively collected and reviewed for associations with anatomic and functional outcomes.

A microscope-mounted OCT system will be used to assess feasibility and utility of imaging during ophthalmic surgical milestones.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: August 2017
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The study population includes any patient requiring ophthalmic surgery

Exclusion Criteria:

• Children under the age of 18

• Cognitive/Mentally impaired or unable to provide consent

• Media opacity precluding OCT scanning

Related Conditions & MeSH terms

• Epiretinal Membrane
• Fuchs Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy
• Macular Hole
• Retinal Detachment
• Retinal Perforations

Locations

Country	Name	City	State
United States	Cole Eye Institute, Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intraoperative OCT	Defined as percentage of cases where OCT was successfully able to be obtained during surgery	3 years
Secondary	Utility of intraoperative OCT	Defined as percentage of cases where the OCT altered surgical decision-making based on surgeon-report on questionnaire	3 years
Secondary	Safety of intraoperative OCT	Defined as the percentage of subjects that experience adverse events that were related to the intraoperative OCT and/or in excess of what might be expected relative to the surgery performed	3 years
Secondary	Time requirements for intraoperative OCT	Defined as the mean number of minutes required to completed intraoperative imaging during a surgical case	3 years