Assessment of visual outcome and quality of life during the course of treatment with intravitreal anti-VEGF injection in patients with diabetic macular edema.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 Visual acuity (log Mar scale) in patients before undergoing intravitreal anti VEGF injections in diabetic macular edema
研究概览
简要总结
Aims and objectives
To assess visual acuity in patients before undergoing intravitreal anti-VEGF injections in diabetic macular edema
To assess the quality of life in patients undergoing intravitreal anti-VEGF injections in diabetic macular edema
To assess visual acuity in patients with diabetic macular edema after intravitreal anti -VEGF injections
To assess quality of life after the course of treatment with intravitreal anti-VEGF injections in diabetic macular edema
Inclusion criteria
Patients with center involving diabetic macular edema requiring anti-VEGF injections
Patients who are already undergoing treatment with intravitreal anti-VEGF injections
Exclusion criteria
Patients with media opacities due to dense cataract , vitreous hemorrhage etc in whom it is difficult to assess posterior segment
Patients with recent stroke less than 3 months who cannot be injected anti-VEGF
Patient with other chronic comorbidities example inability to walk , hearing loss or visual loss due to causes other than DME that may affect quality of life
Patients undergoing other intravitreal injections like steroids
Patients who are not able to have adequate hearing and sight cognition to be able to complete interview questions
Material and methods
The study will be conducted at department of ophthalmology at guru Gobind Singh medical college and hospital, Faridkot, Punjab. After applying inclusion and exclusion criteria, patients selected for study will undergo detailed ophthalmological examination and will be asked visual function questionnaire 25 and score will be calculated
Then after intravitreal anti-VEGF injection patient will be followed up at monthly intervals and again detailed ophthalmological examination will be done including questionnaire regarding patient expectations during intravitreal anti-VEGF injection. Therefore , this study’s aim is to assess visual outcome and quality of life during intravitreal injections in patients with diabetic macular edema.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with center involving diabetic macular edema requiring anti-VEGF injections Patients who are already undergoing treatment with intravitreal anti-VEGF injections.
排除标准
- •Patients with media opacities due to dense cataract , vitreous hemorrhage etc in whom it is difficult to assess posterior segment Patients with recent stroke less than 3 months who cannot be injected anti-VEGF Patient with other chronic comorbidities example inability to walk , hearing loss or visual loss due to causes other than DME that may affect quality of life Patients undergoing other intravitreal injections like steroids Patients who are not able to have adequate hearing and sight cognition to be able to complete interview questions.
结局指标
主要结局
1 Visual acuity (log Mar scale) in patients before undergoing intravitreal anti VEGF injections in diabetic macular edema
时间窗: Visual acuity and NEIVFQ-25 score - baseline, 4 weeks, 8 weeks, 12 weeks after anti-VEGF injection.
2. The quality of life (NEI VFQ25 )in patients undergoing intravitreal anti-VEGF injections in diabetic macular edema
时间窗: Visual acuity and NEIVFQ-25 score - baseline, 4 weeks, 8 weeks, 12 weeks after anti-VEGF injection.
3. Visual acuity (log Mar scale)in patients with diabetic macular edema after intra vitreal anti-VEGF injections at 4 weeks,8 weeks,12 weeks.
时间窗: Visual acuity and NEIVFQ-25 score - baseline, 4 weeks, 8 weeks, 12 weeks after anti-VEGF injection.
次要结局
- Visual acuity (log Mar scale)in patients with diabetic macular edema after intra vitreal anti-VEGF injections at 4 weeks,8 weeks,12 weeks.(Visual acuity (log Mar scale)in patients with diabetic macular edema after intra vitreal anti-VEGF injections at 4 weeks, 8 weeks,12 weeks)
研究者
Dr Neha Sethi
Guru Gobind Singh Medical College and hospital Faridkot