Spectral-domain Optical Coherence Tomography of the Eye

A Prospective, Comparative, Observational Study on Spectral-domain Optical Coherence Tomography of the Eye

An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available SD-OCT machines for both the anterior and posterior segment of the eye.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Diabetic Macular Edema; Macular Edema; Cornea; Retina; Refractive Surgery

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4021
      • Recruiting
      • AKH Linz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 eyes of 100 patients will be included.

Description

Inclusion Criteria:

• Age 21 and older
• Normal eyes or
• Eyes with corneal disease:

Subjects that have any of the following conditions

1. Corneal dystrophy or degeneration
2. Corneal scarring
3. Corneal ulcer
4. Corneal injury
5. Keratoconus
6. Patients who had undergone corneal surgery
7. Patients with other corneal disease or - Eyes with retinal disease:

Subjects that have any of the following conditions:

1. Diabetic macular edema
2. Cystoid macular edema
3. Age related macular degeneration
4. Retinal vascular disorders (e.g. retinal artery occlusion)
5. Epiretinal membrane
6. Choroidal nevus
7. Macular hole
8. Patients who had undergone retinal surgery

9. Patients with other retinal disease or

   • Eyes with glaucoma
   • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

AND

- Written informed consent prior to recruitment

Exclusion Criteria:

Any of the following will exclude a subject from the study:

• Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
• Pregnancy (pregnancy test will be taken in women of reproductive age before enrolment into the trial)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal subjects; Patient with healthy, normal eyes
Eyes with corneal disease; Subjects that have any of the following conditions; Corneal dystrophy or degeneration; Corneal scarring; Corneal ulcer; Corneal injury; Keratoconus; Patients who had undergone corneal surgery; Patients with other corneal disease
Eyes with retinal disease; Subjects that have any of the following conditions: Diabetic macular edema; Cystoid macular edema; Age related macular degeneration; Retinal vascular disorders (e.g. retinal artery occlusion); Epiretinal membrane; Choroidal nevus; Macular hole; Patients who had undergone retinal surgery; Patients with other retinal disease
Eyes with glaucoma; Eyes diagnosed with glaucoma of any type and any stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity as the proportion of anatomical structures that are detectable with the two instruments	Anatomical structures include e.g. sublayers of the cornea, sublayers of the retina, retinal vessels etc.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments	Comparability is analyzed between various biometric values obtained with the two instruments and typical indices of comparability are produced (e.g. intraclass correlation coefficient)	6 months
Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments	Repeatability for various biometric values obtained with the two instruments is analyzed and typical indices of repeatability are produced (e.g. coefficient of variation)	6 months

Collaborators and Investigators

• Sponsor: Augenabteilung Allgemeines Krankenhaus Linz
• Investigators: Principal Investigator: Matthias Bolz, MD, AKh Linz, Augenabteilung

Publications and helpful links

General Publications

• Luft N, Ring MH, Dirisamer M, Mursch-Edlmayr AS, Kreutzer TC, Pretzl J, Bolz M, Priglinger SG. Corneal Epithelial Remodeling Induced by Small Incision Lenticule Extraction (SMILE). Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT176-83. doi: 10.1167/iovs.15-18879.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: November 22, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: November 22, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: OCTComparisonstudy1.1