Appearance of Far Peripheral Retina in Normal Eyes by Ultra-widefield Fluorescein Angiography

NCT ID: NCT02856139

Last Updated: 2016-08-04

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

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-01-31

Brief Summary

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PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using ultra-widefield fluorescein angiography (UWFA).

DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with best corrected visual acuity ≥ 20/20, refractive error \< 3.00D, and without visible retinal pathologic changes under a slit lamp-based condensing lens. The far peripheral retina was detected by UWFA. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to the scleral spur was measured by ultrasound biomicroscopy.

Detailed Description

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PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using ultra-widefield fluorescein angiography (UWFA).

DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with best corrected visual acuity ≥ 20/20, refractive error \< 3.00D, and without visible retinal pathologic changes under a slit lamp-based condensing lens. Demographic and clinical data such as age, sex, and reasons for undergoing FA were collected. The far peripheral retina was detected by UWFA. The fundal fields obtained using the Heidelberg ultra-widefield lens in a single shot and in montage images were compared with those acquired using the Heidelberg conventional 55° lens. The signs at the peripheral retina detected by UWFA were described and grouped. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to the scleral spur was measured by ultrasound biomicroscopy.

Conditions

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Normal Eyes Peripheral Retina

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1 (MB- and VL-)

without mottled fluorescent band (MB) and vascular leakage (VL)

No interventions assigned to this group

2 (MB+ and VL-)

with mottled fluorescent band (MB), without vascular leakage (VL)

No interventions assigned to this group

3 (MB-/+ and VL+)

with or without mottled fluorescent band (MB), with vascular leakage (VL)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* best corrected visual acuity ≥ 20/20
* refractive error \< 3.00D
* without visible retinal pathologic changes under a slit lamp-based condensing lens

Exclusion Criteria

* history of ocular surgery
* presence of ocular or systemic diseases
* opacity of refractive media, which interfered with the peripheral retina image quality
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Lin Lu

the Director of the Fundus Center of Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2016036

Identifier Type: -

Identifier Source: org_study_id

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