Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.
Not Applicable
Recruiting
- Conditions
- Macular edema secondary to retinal vein occlusion (RVO)
- Registration Number
- JPRN-UMIN000020326
- Lead Sponsor
- niversity of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
Not provided
Exclusion Criteria
1) Previous history of vitreoretinal surgery 2) Previous history of ophthalmic disorders except mild refractive errors and mild cataract 3) Within 90 days of macular edema treatment [ including sub-Tenon triamcinolone acetonide (STTA), intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), intravitreal aflibercept (IVA), topical steroid, carbonic anhydrase inhibitors (CAI) ] 4) Within 90 days of intraocular surgery 5) Contralateral eye of RVO 6) Poor control of hypertension (HT) and diabetic mellitus (DM) 7) Within 30 days of laser treatment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in horizontal and vertical metamorphopsia scores using M-charts from baseline at Month 12.
- Secondary Outcome Measures
Name Time Method Mean change in BCVA from baseline at Month 12 Mean change in contrast sensitivity from baseline at Month 12 Mean change in central macular thickness (CRT) from baseline at Month 12 Presence/absence of inner retinal cyst over time until Month 12 Mean change in thickness of inner retinal layer from baseline at Month 12 Mean change in VR-QOL (subscale and composite scores in NEI VFQ-25) at Month 0,3,6 and 12 Adverse events (AEs) and Serious adverse events (SAEs)