Spectral-domain Optical Coherence Tomography of the Eye

NCT02614625 | Unknown

• 1 other identifier: OCTComparisonstudy1.1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cornea; Retina; Refractive Surgery; Macular Edema; Diabetes; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments

  6 months

• Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments

  6 months

Study Arms (4)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 eyes of 100 patients will be included.

You may qualify if:

• Age 21 and older
• Normal eyes or
• 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 or - Eyes with retinal disease:
• Subjects that have any of the following conditions:
• Diabetic macular edema
• Cystoid macular edema
• Age related macular degeneration

You may not qualify if:

• 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)

Sponsors & Collaborators

• Augenabteilung Allgemeines Krankenhaus Linz: lead

Study Sites (1)

AKh Linz

Linz, Upper Austria, 4021, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 27409470 DERIVED

MeSH Terms

Conditions

Corneal Diseases; Macular Edema; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Matthias Bolz, MD

  AKh Linz, Augenabteilung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaus Luft, MD

CONTACT

+43 732 7806; nikolaus.luft@akh.linz.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: November 25, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

AU (1)