Clinical trial NCT04075695: Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
Official title: Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Vein Occlusion
Keywords: ischemic index
Ultra-wide field fundus fluorescein angiography
vascular leakage index
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: The changes of ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion by ultra-wide field fluorescence angiography (UWFA)

Detailed description: In this study, the ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion will be evaluated by ultra-wide field fluorescence angiography (UWFA). UWFA has a wider range than conventional angiography, and can clearly observe the peripheral retina. The purpose of this study is to quantitatively analyze these changes and investigate the effect on macular edema and neovascularization secondary to retinal vein occlusion.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or more
2. Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
3. Duration of RVO not more than 4 months
4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of RVO are also considered naive
5. Patient who agrees to participate to the study and who has given his/her written, informed consent

Exclusion Criteria:

1. Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period
2. Active or suspected ocular or periocular infection
3. Active severe intraocular inflammation
4. RVO complicated with neovascularization
5. Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
6. Patient already included in the study for the treatment of the fellow eye
7. Pregnant or breastfeeding woman
8. Lack of effective contraception for women of childbearing age
9. Patient taking part in an interventional study

Primary outcomes:
measure: Change in non-perfused areas in different retinal area
timeFrame: Baseline and1，2，3，6，9and 12 months
Secondary outcomes:
measure: Change in best corrected visual acuity
timeFrame: Baseline and1，2， 3, 6, 9 and 12 months
measure: Change in central macular thickness
timeFrame: Baseline and1，2， 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Renmin Hospital of Wuhan University
role: PRINCIPAL_INVESTIGATOR
References: