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Spectral-domain Optical Coherence Tomography of the Eye

NCT ID: NCT02614625

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cornea Retina Refractive Surgery Macular Edema Diabetes Diabetic Macular Edema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal subjects

Patient with healthy, normal eyes

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eyes with glaucoma

Eyes diagnosed with glaucoma of any type and any stage

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augenabteilung Allgemeines Krankenhaus Linz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Bolz, MD

Role: PRINCIPAL_INVESTIGATOR

AKh Linz, Augenabteilung

Locations

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AKh Linz

Linz, Upper Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Nikolaus Luft, MD

Role: CONTACT

[email protected]
+43 732 7806 ext. 1050

References

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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.

Reference Type DERIVED
PMID: 27409470 (View on PubMed)

Other Identifiers

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OCTComparisonstudy1.1

Identifier Type: -

Identifier Source: org_study_id