Comparison of visual performance and quality of vision between two trifocal intraocular lenses randomized clinical trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Prashant Tomar
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses.
概览
简要总结
This randomized controlled clinical trial aims to compare the visual performance and quality of vision after implantation of two different trifocal intraocular lenses in patients undergoing phacoemulsification for age-related cataract. Fifty patients aged 18 years or above with senile cataract will be recruited from the Department of Ophthalmology, Command Hospital (Eastern Command), Kolkata. Eligible patients without ocular comorbidities such as glaucoma, macular degeneration, or significant corneal astigmatism (>1.0 D) will be randomized into two equal groups of 25 each. Group A will receive BVI PhysIOL trifocal intraocular lenses, and Group B will receive Tecnis Synergy trifocal intraocular lenses.
Preoperative evaluation will include visual acuity assessment, slit-lamp examination, intraocular pressure measurement, and fundus examination. Standard phacoemulsification with IOL implantation will be performed in all cases. Postoperative follow-up will be done at one week and one month.
The primary outcomes will include uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm). Secondary outcomes will include assessment of glare and halos using the NEI near vision subscale and evaluation of visual quality using the Rasch-scored Quality of Vision (Q of V) questionnaire.
The total study duration will be 18 months for data collection and 2 months for data analysis. Ethical clearance has been obtained from the Institutional Ethical Committee, and written informed consent will be taken from all participants. The study will adhere to the principles of the Declaration of Helsinki and good clinical practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged greater than 18 years with age-related cataract.
- •Willing for trifocal intraocular lens implantation.
- •Willing to participate in the study and provide written informed consent.
- •Able to comply with postoperative follow-up schedule.
排除标准
- •History of previous ocular surgery or trauma.
- •Presence of ocular comorbidities such as glaucoma, diabetic retinopathy, or macular degeneration.
- •Corneal opacity or any other condition affecting visualization of intraocular structures.
- •Systemic diseases that may affect vision or healing, such as uncontrolled diabetes mellitus or multiple sclerosis.
- •Intraoperative complications such as posterior capsular rupture or zonular weakness.
- •Psychiatric illness or cognitive impairment that affects the ability to complete subjective questionnaires.
- •Patients with unrealistic expectations regarding postoperative visual outcomes.
结局指标
主要结局
Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses.
时间窗: Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses.
次要结局
- 1. Assessment of glare & halos using NEI near vision subscale — at 4 weeks postoperatively.
研究者
Prashant Tomar
Command Hospital Eastern Command