NCT02856139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 2, 2016

Last Update Submit

August 2, 2016

Conditions

Normal EyesPeripheral Retina

Keywords

ultra-widefield fluorescein angiographyperipheral retinanormal eyes

Outcome Measures

Primary Outcomes (1)

  • Ultra-widefield fluorescein angiography findings at the far peripheral retina of normal eyes

    from November 2014 to January 2016

Secondary Outcomes (1)

  • Ciliary body thickness

    from November 2014 to January 2016

Study Arms (3)

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)

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Officials

  • Lin Lu, MD, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Director of the Fundus Center of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)