Visual Outcomes and Satisfaction in patients undergoing Monofocal Intraocular lens (IOL) Vs Multi-Focal IOL Vs Extended Depth of Focus (EDOF) IOL Implantation via Phacoemulsification.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Visual Acuity differences across Near, Intermediate and Far vision will be measured and compared across Monofocals, Multifocals, EDOF IOLs. Multifocals should give spectacle free good visual acuity across all ranges. EDOF good visual acuity across Far and Intermediate vision.
研究概览
简要总结
This study will employ a prospective, controlled, comparative trial design with the study duration being 1.5 years in Aravind Eye Hospital, Chennai. Individuals who meet the specified inclusion and exclusion criteria will be invited to participate in the study after counselling and obtaining consent.
Patients will be in either the EDOF IOL or Multifocal IOL group or Monofocal group.
Pre-operatively VA, Refraction, Slit lamp, Fundus exam, A scan biometry VA, Refraction, Slit lamp, Fundus exam, A scan biometry, iTrace VA, Refraction, Slit lamp, Fundus exam, A scan biometry
POD 1ST DAY VA, Slit lamp, Fundus exam
POD 3RD WEEK VA, Refraction, Slit lamp, Fundus exam
POD 3RD MONTH VA, Refraction, IND - VFQ, Slit lamp, Fundus exam, iTrace Patient satisfactions surveys (Indian – Visual Functioning Questionnaire) (3), visual acuity assessments (Vision, Refraction, A-scan biometry by Barrett II Universal formula, IOP, Slit lamp and fundus examination will be recorded at baseline (pre-operatively) and post operatively. Follow up examinations will be conducted on Post – operative Day 1, 3rd week and 3rd month, measuring the same parameters mentioned above. Visual outcomes will be measured in terms of UCVA and BCVA for Near Vision, Intermediate Vision and Far Vision in logMAR form. The tests being performed are already a part of the Standard Operating Protocol (SOP) of the hospital for patients undergoing cataract surgery. Additions are post- operative iTrace and Indian NEI - VFQ standardized validated questionnaire which will be furnished to the patient in his/her language of understanding and comprehension.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •A) Patients aged 40 and above.
- •B) Patients advised surgery, consenting and willing to undergo cataract surgery by phacoemulsification / MICS.
- •C) Uneventful phacoemulsification / MICS surgery.
排除标准
- •A) Patients with chronic co-morbidities like Diabetes Mellitus, Hypertension.
- •B) Any pre-existing corneal pathology/opacity leading to altered vision.
- •C) Any pre-existing retinal or macular pathology leading to sub-optimal post-op vision.
- •D) Inherited ocular conditions leading to Guarded visual prognosis.
- •E) Previously IOL implanted patient undergoing lens exchange procedure.
结局指标
主要结局
Visual Acuity differences across Near, Intermediate and Far vision will be measured and compared across Monofocals, Multifocals, EDOF IOLs. Multifocals should give spectacle free good visual acuity across all ranges. EDOF good visual acuity across Far and Intermediate vision.
时间窗: Post Operative Day 1, Post Operative Day 21 (3rd week), Post operative Day 90 (3rd month)
次要结局
- Patient satisfaction via IND-VFQ questionnaire on post operative visit.(-Spectacle independence)
研究者
Manan Mistry
Aravind Eye Hospitals