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

Normal Eyes Clinical Trial

Official title:

The Director of the Fundus Center of Zhongshan Ophthalmic Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856139
• Other study ID #: 2016036
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 2, 2016
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Normal Eyes
• Peripheral Retina

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultra-widefield fluorescein angiography findings at the far peripheral retina of normal eyes		from November 2014 to January 2016	No
Secondary	Ciliary body thickness		from November 2014 to January 2016	No