To compare visual outcomes and patient satisfaction levels in patients undergoing implantable Collamer lens ICL implantation versus Small Incision Lenticule Extraction in cases of moderate myopia and myopic astigmatism
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1) Objectively measure pre- and post-operative higher-order ocular aberrations, including spherical aberration, vertical coma, trefoil, tetrafoil, and contrast sensitivity and subjectively use a quality of vision questionnaire to assess the same.
研究概览
简要总结
Over the past 20 years, refractive surgery has witnessed significant advancements, including Small Incision Lenticule Extraction (SMILE) and Implantable Collamer Lens (ICL). SMILE’s flapless design reduces postoperative dryness and offers biomechanical stability, making it a safe and effective option for patients with adequate corneal thickness and no irregularities. On the other hand, ICL is a minimally invasive procedure that implants a Collamer lens in phakic eyes, correcting a more comprehensive range of myopic correction (0 to -18.00 D) with a short recovery time.
While ICL is the preferred surgery for high myopia, there are limited studies on its use in correcting mild and moderate myopia. Comparing EVO-ICL and laser-assisted in situ keratomileusis (LASIK), ICL was found to be safer, more predictable, and more stable, with better contrast sensitivity and lower higher-order aberrations (HOAs). The current literature primarily compares the visual outcomes of ICL and SMILE in patients with high myopia.
The most extensive study conducted in this group was by Aruma et al where 32 eyes of 20 patients underwent EVO-ICL implantation, and 35 eyes of 19 patients underwent SMILE. Changes in coma after ICL were significantly less than after SMILE. The leading complaints after ICL and SMILE were halos (84.4%) and blurred vision (65.7%). A study by Ganesh et al in Indian eyes compared three procedures: Toric-ICL. Femtosecond LASIK and SMILE in 30 patients with low to moderate myopia over a one-year follow-up period concluded that the Quality of vision and patient satisfaction with Toric ICL and SMILE were similar and better than Femtosecond LASIK.
There are very few long-term studies, especially Indian studies, that compare the effects on vision quality objectively and subjectively after both procedures in cases of moderate myopia and myopic astigmatism; hence, the need to carry out this study. A more extensive population-based comparative analysis would be needed to compare the visual performance between the two procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Spherical equivalent of negative 3 to negative 6 Dioptres Refractive cylinder less than or equal to 2 Dioptres Best spectacle-corrected visual acuity of 20 by 40 or better A spherical or cylindrical error that has progressed at negative half Dioptres or less per year before the baseline measurement.
- •The contact lens must have been removed at least two weeks before the baseline measurement.
- •No evidence of irregular astigmatism on corneal topography Anterior chamber depth more than or equal to two point eight millimetre Corneal endothelial cell count more than or equal to two thousand cells per square millimetre.
排除标准
- •Progressive or unstable myopia and astigmatism Clinical or corneal topographic evidence of keratoconus Residual recurrent or active ocular disease and retinal disease Previous corneal surgery Thinnest Pachymetry les than or equal to four hundred ninety micrometre Residual Stromal Bed less than or equal to two hundred and eighty micrometre in patients undergoing Small Incision Lenticule extraction Taking systemic medications and systemically immunocompromised or systemic diseases likely to affect wound healing such as diabetes connective tissue disease and severe atopy pregnant or nursing females.
结局指标
主要结局
1) Objectively measure pre- and post-operative higher-order ocular aberrations, including spherical aberration, vertical coma, trefoil, tetrafoil, and contrast sensitivity and subjectively use a quality of vision questionnaire to assess the same.
时间窗: Day 01 | 01 week | 01 month | 03 months | 06 months | 12 months | 18 months and 21 months
次要结局
- Assessment of Uncorrected and corrected visual acuity, efficacy and safety of the procedure, and endothelial cell count between two groups.
研究者
Supriya Dhar
Army Hospital RR Delhi Cantt