To Analyse Acute Peripapillary Angiographic and Retinal Nerve Fibre Layer changes following intravitreal anti-VEGF injections: a case-control study with and without use of Brimonidine eye drops.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- CHANGE IN PERIPAPILLARY RETINAL NERVE FIBRE LAYER THICKNESS AND PRIPAPILLARY VASCULAR PERFUSION DENSITY
研究概览
简要总结
TITLE: ANALYSIS OF ACUTE PERIPAPILLARY ANGIOGRAPHIC AND RETINAL NERVE FIBRE LAYER CHANGES FOLLOWING INTRAVITREAL ANTI-VEGF INJECTIONS: A CASE CONTROL STUDY WITH AND WITHOUT BRIMONIDINE EYE DROPS.
OBJECTIVE:
TO EVALUATE THE ACUTE EFFECTS OF INTRAVITREAL ANTI-VEGF INJECTIONS ON PERIPAPILLARY RETINAL NERVE FIBRE LAYER (RNFL) THICKNESS, AND MICROVASCULATURE(VESSEL AND PERFUSION DENSITY) USING OCT AND OCT-A. THIS STUDY ALSO AIMS TO ASSESS THE PROTECTIVE ROLE OF BRIMONIDINE 0.15 PERCENT PROPHYLAXIS AGAINST THESE CHANGES.
STUDY DESIGN:
CASE-CONTROL STUDY (AUGUST 2025-JULY 2026) AT SANKARA EYE HOSPITAL, BENGALURU.
- CASES: EYES PRE-TREATED WITH BRIMONIDINE 0.15 PERCENT EYE DROP , 30 MINUTES BEFORE ANTI-VEGF INJECTION
-CONTROLS: EYES WITHOUT BRIMONIDINE.
SAMPLE SIZE:
220 EYES(110 PER GROUP), ACCOUNTING FOR EXCLUSIONS, POWERED TO DETECT A MEAN DIFFERENCE OF 2.3 IN RNFLTHICKNESS (STANDARD DEVIATION IS EQUAL TO 7, 90 PERCENT POWER, 95 PERCENT CONFIDENCE INTERVAL
METHODOLOGY:
-BASELINE AND POST-INJECTION (WITHIN 60 MINUTES, PREFERABLY AT 30 MINUTES) MEASUREMENTS OF IOP(TONOPEN), RNFL THICKNESS(OCT), AND PERIPAPILLARY MICROVASCULATURE (OCT-A)
-STATISTICAL ANALYSIS USING SPSS (PEARSON’S CORRELATION FOR IOP-RNFL AND IOP-VASCULAR CHANGES; P LESS THAN 0.05 SIGNIFICANT).
EXPECTED OUTCOMES:
-
REDUCED RNFL THINNING AND MICROVASCULATURE COMPROMISE IN BRIMONIDINE-TREATED EYES
-
LOWER IOP SPIKES IN THE BRIMONIDINE GROUP
-
POSITIVE CORRELATION BETWEEN IOP RISE AND RNFL AND PERFUSION LOSS IN CONTROLS
SIGNIFICANCE:
POTENTIAL TO VALIDATE BRIMONIDINE’S NEURO-PROTECTIVE ROLE, OPTIMIZE SAFETY PROTOCOLS, AND GUIDE PROPHYLACTIC USE IN HIGH-RISK PATIENTS (GLAUCOMA SUSPECTS)
ETHICS:
APPROVED BY INSTITUTIONAL SCIENTIFIC AND ETHICS COMMITTEES
KEYWORDS:
ANTI-VEGF, BRIMONIDINE, RNFL, OCT, OCT-A, IOP SPIKES, PERIPAPILLARY MICROVASCULATURE
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENTS INDICATED FOR INTRAVITREAL ANTI-VEGF INJECTION (EG-DIABETIC MACULAR EDEMA, AGE-RELATED MACULAR DEGENERATION, RETINAL VEIN OCCLUSIONS) 2)BEST CORRECTED VISUAL ACUITY MORE THAN 6/60 3)AGE GREATER THAN 18 YEARS 4)CLEAR MEDIA 5)PHAKIC OR PSEUDOPHAKIC EYES 6)GOOD FIXATION ABILITY 7)INTRAOCULAR PRESSURE LESS THAN 21 MMHG BEFORE INJECTION 8)CONSENT TO PARTICIPATE IN THE STUDY.
排除标准
- •KNOWN ALLERGY TO BRIMONIDINE 0.15 PERCENT EYE DROP 2)USE OF ANY INTRAOCULAR PRESSURE LOWERING EYE DROPS WITHIN THE PAST 2 WEEKS.
- •HISTORY OF UVEITIS OR OCULAR INFLAMMATION 4)PREVIOUS VITRECTOMY OR GLAUCOMA SURGERY IN THE STUDY EYE 5)KNOWN CASE OF GLAUCOMA 6)MEDIA OPACITIES (DENSE CATARACT, CORNEAL OPACITY, VITREOUS HAEMORRHAGE) 7)POOR OCT, OCT-A IMAGE QUALITY 8)HIGH MYOPIA (MORE THAN -6.00 D SPHERICAL EQUIVALENT OR AXIAL LENTH MORE THAN 26.5MM) 9)CONCURRENT RETINAL PATHOLOGIES LIKE RETINAL DETACHMENT, MACULAR HOLE 10)APHAKIC EYES 11)PATIENTS UNDERGOING TREATMENT WITH AFLIBERCEPT 0.1ML.
结局指标
主要结局
CHANGE IN PERIPAPILLARY RETINAL NERVE FIBRE LAYER THICKNESS AND PRIPAPILLARY VASCULAR PERFUSION DENSITY
时间窗: 30 MINUTES BEFORE AND AFTER THE INTRAVITREAL ANTI-VEGF INJECTION.
次要结局
- CHANGE IN INTRAOCULAR PRESSURE(BEFORE AND 5 MINUTES AFTER INTRAVITREAL ANTIVEGF INJECTION)
- CORRELATION BETWEEN INTRAOCULAR PRESSURE AND PERIPAPILLARY RETINAL NERVE FIBRE LAYER AND VASCULAR CHANGES(VESSEL DENSITY, PERFUSION DENSITY)
- SAFETY AND FEASIBILITY OF BRIMONIDINE USE
研究者
PAVITHRA R V
SANKARA EYE HOSPITAL