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

The Director of the Fundus Center of Zhongshan Ophthalmic Center

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.

Study Overview

• Status: Completed
• Conditions: Normal Eyes; Peripheral Retina

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of the fundus outpatient clinic in Zhongshan ophthalmic center who meet the standard of inclusion criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
1 (MB- and VL-); without mottled fluorescent band (MB) and vascular leakage (VL)
2 (MB+ and VL-); with mottled fluorescent band (MB), without vascular leakage (VL)
3 (MB-/+ and VL+); with or without mottled fluorescent band (MB), with vascular leakage (VL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ultra-widefield fluorescein angiography findings at the far peripheral retina of normal eyes	from November 2014 to January 2016

Secondary Outcome Measures

Outcome Measure	Time Frame
Ciliary body thickness	from November 2014 to January 2016

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Lin Lu, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: ultra-widefield fluorescein angiography; peripheral retina; normal eyes
• Other Study ID Numbers: 2016036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No