Spectral-domain Optical Coherence Tomography of the Eye

A

Augenabteilung Allgemeines Krankenhaus Linz

Status

Unknown

Conditions

Retina
Diabetes
Diabetic Macular Edema
Macular Edema
Refractive Surgery
Cornea

Study type

Observational

Funder types

Other

Identifiers

NCT02614625
OCTComparisonstudy1.1

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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
  • 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 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)

Trial design

100 participants in 4 patient groups

Normal subjects
Description:
Patient with healthy, normal eyes
Eyes with corneal disease
Description:
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
Description:
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
Description:
Eyes diagnosed with glaucoma of any type and any stage

Trial contacts and locations

1

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Central trial contact

Nikolaus Luft, MD

Data sourced from clinicaltrials.gov

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