Spherical Implantable Collamer Lens With Postoperative Adjunctive LASIK in the Treatment of High Compound Hyperopic Astigmatism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Post-operative visual acuitiy
研究概览
简要总结
This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Later, a laser procedure (LASIK) is performed to fine-tune the results for even better clarity.
详细描述
To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism. In this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative hyperopic sphere of ≥+3.50 D
- •Astigmatism of ≥+2.00 D
- •Stable refraction for the previous 12 months
- •Age older or equal to 18 years
- •Anterior chamber depth (ACD) from corneal endothelium to anterior lens capsule of 3.0 mm or greater
排除标准
- •Age younger than 18 years
- •Patients lost to follow-up
- •Cataract formation
- •History of glaucoma or retinal detachment
- •Macular degeneration
- •Diabetic retinopathy
- •History of ocular inflammation
- •Signifcant irregular corneal topography
- •Evidence of inconsistent imaging from dry eyes
结局指标
主要结局
Post-operative visual acuitiy
时间窗: 90 days after lasik surgery
postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)
次要结局
- Manifest refraction(90 days after lasik surgery)
- Spherical (SEQ) and defocus equivalent (DEQ)(90 days after LASIK surgery)
- Efficacy Index and Safety Index(90 days after LASIK surgery)
- Astigmatism Vector Analysis(90 days after LASIK surgery)
研究者
Daniel Li
Resident Physician
McGill University