Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Uncorrected and distance visual acuity, Wavefront aberrometry
研究概览
简要总结
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.
References
- Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Outcomes of wavefrontguided laser in situ keratomileusis using a new-generation Hartmann-Shack
aberrometer in patients with high myopia. J Cataract Refract Surg. 2015; 41(9):
1810-9.
- Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Wavefront-Guided
Photorefractive Keratectomy with the Use of a New Hartmann-Shack
Aberrometer in Patients with Myopia and Compound Myopic Astigmatism. J
Ophthalmol. 2015; 2015: 514837.
- Shaheen MS, Shalaby Bardan A, Piñero DP, Ezzeldin H, El-Kateb M, Helaly
H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a HighResolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus.
Cornea. 2016; 35(7): 946-53.
- Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye
disease after refractive surgery: comparative outcomes of small incision lenticule
extraction versus LASIK. Ophthalmology. 2015; 122(4): 669-76.
- Reinstein DZ, Archer TJ, Gobbe M. Small incision lenticule extraction (SMILE)
history, fundamentals of a new refractive surgery technique and clinical
outcomes. Eye Vis (Lond). 2014;1:3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
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 0.8 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 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 interocular difference of more than 1.00 diopter 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
Uncorrected and distance visual acuity, Wavefront aberrometry
时间窗: Pre-surgery, 1 month, 3 month, 6 month
次要结局
- Corneal tomography, Biomechanics of the cornea, ocular surface discomfort (OSDI score)(Pre-surgery, 1 month, 3 month, 6 month)