Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in visual acuity measured as Logarithm of manifest refraction
研究概览
简要总结
The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical changes and inflammatory profile of normal eyes (matched for age, refraction and corneal thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for higher order aberrations.
详细描述
iDesign is a promising new technique to treat myopia with astigmatism using ocular aberrations measured with a high resolution wavefront sensor.[1,2] Early studies with iDesign platform has established its safety and efficacy in correction of myopia with fewer patients reporting night vision problems.[1,2] In keratoconus, iDesign has also provided excellent outcomes following collagen crosslinking.3 SMILE is a recent technique that eliminates creation of flap and appears to achieve similar refractive outcomes as conventional LASIK but with less dryness, less inflammation and faster wound healing.[4,5] SMILE corrects lower order aberrations only.[4,5] Thus, a comparative assessment of iDesign and SMILE is necessary since iDesign can potentially give better visual outcomes with lower volume of tissue removal. If lower volume of tissue is removed, it is also hypothesized that the corneal would be more stable biomechanically.[5] Further, SMILE does not provide any correction of higher order aberrations. With the inclusion of higher order aberrations in the iDesign treatment plan, it is hypothesized that both short and long term outcomes will be better with iDesign than with SMILE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should be between 18 to 50 years of age.
- •Patient must have stable myopia for a minimum period of one year (a change of 0.25D or less) as documented by prior clinical records or current spectacle correction.
- •Patient must have a corrected distance visual acuity (CDVA) of 20/25 or better,
- •Patient must have a spherical equivalent refraction less than -10D
- •Patient must have refractive astigmatism less than 3D.
排除标准
- •Patient must not have a central corneal thickness (CCT) less than 480 micrometer
- •Patient must not have a calculated residual stromal bed thickness of less than 250 micrometer after the surgery
- •Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery.
- •Patient must not have an inter-ocular difference of more than 1.00 diopter (D) of spherical or 0.50 D of cylindrical refractive error.
- •Patient must not be on chronic systemic steroids or other medication that can affect wound healing.
- •Patient must not be allergic to primary or alternative medications.
- •Patient must not be using rigid contact lenses for the last three weeks or soft contact lenses for at least 1 week before the preoperative evaluation.
结局指标
主要结局
Change in visual acuity measured as Logarithm of manifest refraction
时间窗: Post surgery over a period of 1 year
Uncorrected and corrected distance visual acuity
次要结局
- Change in Corneal curvature in Diopter(Post surgery over a period of 1 year)
- Change in deformation of the cornea(Post surgery over a period of 1 year)
- Change in ocular surface dryness and/or pain(Post surgery over a period of 1 year)
- Change in wavefront aberrations described by Zernike Polynomials(Post surgery over a period of 1 year)
研究者
Dr Rohit Shetty
Doctor
Narayana Nethralaya