Clinical trial NCT02856139: Appearance of Far Peripheral Retina in Normal Eyes by Ultra-widefield Fluorescein Angiography
Official title: The Director of the Fundus Center of Zhongshan Ophthalmic Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes
Peripheral Retina
Keywords: ultra-widefield fluorescein angiography
peripheral retina
normal eyes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 61
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the fundus outpatient clinic in Zhongshan ophthalmic center who meet the standard of inclusion criteria.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultra-widefield fluorescein angiography findings at the far peripheral retina of normal eyes
timeFrame: from November 2014 to January 2016
Secondary outcomes:
measure: Ciliary body thickness
timeFrame: from November 2014 to January 2016
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lin Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: