Comparative Analysis of the Stability of Two Toric Intraocular Lenses Using Multimodal Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the rotational stability of toric intraocular lenses (IOLs) in pseudophakic eyes over a 6-
研究概览
简要总结
This study focuses on assessing the positional stability of toric intraocular lenses (IOLs) implanted during cataract surgery for correction of corneal astigmatism. The success of a toric IOL depends on its rotational and axial stability within the capsular bag—any rotation, tilt, or decentration can significantly reduce the astigmatic correction and degrade visual quality.
The research compares two types of toric IOLs with different haptic designs—Type A (L-haptic) and Type B (C-loop)—to evaluate their stability using multimodal imaging techniques. These include Anterior Segment Optical Coherence Tomography (AS-OCT) for measuring IOL tilt, decentration, and anterior chamber depth, and iTrace aberrometry for assessing IOL rotation, higher-order aberrations (HOAs), and visual quality indices such as the Strehl ratio.
This is a prospective randomized controlled trial, with patients stratified based on corneal toricity (low vs high). Following phacoemulsification and toric IOL implantation, postoperative assessments are done at 1 month, 3 months, and 6 months, focusing primarily on rotational stability and secondarily on optical alignment, image quality, and visual acuity outcomes.
The findings are expected to help determine which haptic design provides superior postoperative stability, leading to more predictable refractive results, improved patient satisfaction, and enhanced guidelines for IOL selection in routine cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of cataract with regular corneal astigmatism requiring Toric IOL implantation
- •Axial length ranging between 22 mm and 25 mm
- •Against-the-rule ATR astigmatism 0.75 D or with-the-rule WTR astigmatism More than 1.00 D Preoperatively
- •Willingness and ability to comply with postoperative follow-up for a minimum period of 6 months
- •Rhexis size 5-5.5 mm measured intraoperatively using verion guided system.
排除标准
- •History of prior ocular surgery
- •History of ocular trauma
- •Rhexis size 5 mm and 5.5mm.
- •Corneal conditions that could adversely affect visual outcomes, such as scarring or endothelial dysfunction
- •Presence of irregular or decentered pupils
- •Clinically significant zonular weakness
- •History of uveitis or preexisting retinal pathologies
- •Refusal to randomization or unwillingness to procure assigned lens prior to surgery.
结局指标
主要结局
To evaluate the rotational stability of toric intraocular lenses (IOLs) in pseudophakic eyes over a 6-
时间窗: 1 month ,3 month ,6 month
month follow-up period and assess their impact on visual function
时间窗: 1 month ,3 month ,6 month
次要结局
- To evaluate the positional stability of Toric intraocular lenses over a 6 month follow - up period and(assess their impact on visual function. This will be achieved by analyzing the following parameter)
研究者
Atif Irfan
PGI chandigarh