Stabilizing Myopia by Accelerating Reshaping Technique (SMART)-Study Three Year Outcomes and Overview

Abstract

Objectives: The SMART study is a three-year, longitudinal, multicenter evaluation comparing corneal reshaping contact lenses (CRCL) influence on the progression of myopia in children (age 8 to 14 at enrollment) to the wearing of soft silicone hydrogel contact lenses (SCL) worn on a daily wear basis with monthly replacement. This study represents one of the largest patient enrollment with ten investigators and adds to the literature by verifying the outcomes of smaller enrolled investigations strengthen the outcomes of corneal reshaping techniques. Methods:At enrollment 172 subjects were fit with corneal reshaping contact lenses worn overnight on a nightly basis (Emerald design by Euclid Systems) and 110 subjects were fit with silicone hydrogel contact lenses on a daily wear monthly-replacement basis (Pure Vision by Bausch & Lomb). Visits were conducted at 24 hours, one week, one month, three months, and every six months thereafter for three years. A regression protocol was conducted for the CRCL subjects at each yearly visit for three years by discontinuing lens wear and monitoring for stability of refraction and topography for consecutive visits until baseline was reached. Results:The outcome of the three-year investigation indicated that myopia progressed at a statistically significantly higher degree in the SCL group as compared to the CRCL group. Mean spherical equivalent change in myopia for the SCL group was -1.03 ± 0.58 diopters, vs. CRCL group -0.13 ± 0.62 diopters s (p < 0.0001). There were no cases of reduced best corrected visual acuity for three years for either group. There were no significant adverse events in either group from baseline to the three-years. 80% of eyes were successfully fit with CRCL with the first lens fit empirically and 95% of eyes were fit successfully with only one lens change. There was no significant difference between dropout rates during the three year study between the two groups. Conclusion:The three year longitudinal study found that myopia progressed at a significantly higher degree in the SCL vs. CRCL subjects. . Efficacy, safety, and dropout rate of corneal reshaping in our sample population appears to be comparable to wearing SCL.

Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial

“…Although the OK group progressed −0.12 D and the control (soft lens) group progressed −1.01 D, the outcomes failed to show AL differences measured by ultrasound between the test and control groups. The authors explained that this finding was due to the high variability between the multiple sites of acquisition [ 32 ]. In our case, one expert examiner collected the data using the same procedure and instrument.…”

Success Rate of Incorporating Corneal Refractive Therapy into 3 Different Ophthalmology Practices

“…10 Studies, such as Stabilizing Myopia by Accelerated Reshaping Technique (SMART), Childrens Overnight Orthokeratology Investigation (COOKI), Myopia Control with Orthokeratology Contact Lenses in Spain (MCOS), and Influence of overnight orthokeratology on axial length elongation in childhood myopia have been conducted to test the safety of overnight orthokeratology lenses in children. [11][12][13][14] The SMART study showed no instances of infiltrative keratitis in the orthokeratology patients and only 5% of the patients showed corneal staining. 12 The COOKI study showed higher occurrence of corneal staining but the severity of the corneal staining seemed to be very low (1.6 on a scale of 1-4).…”

“…[11][12][13][14] The SMART study showed no instances of infiltrative keratitis in the orthokeratology patients and only 5% of the patients showed corneal staining. 12 The COOKI study showed higher occurrence of corneal staining but the severity of the corneal staining seemed to be very low (1.6 on a scale of 1-4). The degree of staining matched that of typical contact lens wear.…”

Visual Acuity Stability of Ortho-K Treatment in a Child with Low Myopia: A Case Study

“…This condition can decrease the quality of life in children and adult 4 . Progressivity of myopia can be slowed by using ortho-K lens (orthokeratology) 7 .…”

“…These changes is temporary and do not repair the cause of myopia 8 . This technique is safe and effective especially for children to reduce myopia progressivity 6,7 . Often complication from this lens are: corneal staining (usually mild, can be monitored and easily handled) and microbial keratitis.…”