Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE

Myopia Clinical Trial

Official title:

Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03001401
• Other study ID #: C/2016/09/07
• Status: Recruiting
• Phase: Phase 4
• First received: December 15, 2016
• Last updated: December 19, 2016
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Narayana Nethralaya
• Contact: Abhijit Sinha Roy, PhD
• Phone: +919740566833
• Email: asroy27[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients should be between 18 to 50 years of age.

2. 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.

3. Patient must have a corrected distance visual acuity (CDVA) of 20/25 or better,

4. Patient must have a spherical equivalent refraction less than -10D

5. Patient must have refractive astigmatism less than 3D.

Exclusion Criteria:

1. Patient must not have a central corneal thickness (CCT) less than 480 micrometer

2. Patient must not have a calculated residual stromal bed thickness of less than 250 micrometer after the surgery

3. Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery.

4. 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.

5. Patient must not be on chronic systemic steroids or other medication that can affect wound healing.

6. Patient must not be allergic to primary or alternative medications.

7. 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• iDesign
One group will under go standard LASIK using iDesign platform (J&J, USA). Visual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.
• SMILE
The other group will undergo SMILE for treatment refractive error (Carl Zeiss, Germany). isual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.

Locations

Country	Name	City	State
India	Narayana Nethralaya	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Narayana Nethralaya

Country where clinical trial is conducted

India, 

References & Publications (8)

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 Apr;122(4):669-76. doi: 10.1016/j.ophtha.2014.10.004. — View Citation

Matalia J, Francis M, Tejwani S, Dudeja G, Rajappa N, Sinha Roy A. Role of Age and Myopia in Simultaneous Assessment of Corneal and Extraocular Tissue Stiffness by Air-Puff Applanation. J Refract Surg. 2016 Jul 1;32(7):486-93. doi: 10.3928/1081597X-20160512-02. — View Citation

McNabb RP, Farsiu S, Stinnett SS, Izatt JA, Kuo AN. Optical coherence tomography accurately measures corneal power change from laser refractive surgery. Ophthalmology. 2015 Apr;122(4):677-86. doi: 10.1016/j.ophtha.2014.10.003. — View Citation

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 Oct 16;1:3. doi: 10.1186/s40662-014-0003-1. Review. — View Citation

Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Outcomes of wavefront-guided laser in situ keratomileusis using a new-generation Hartmann-Shack aberrometer in patients with high myopia. J Cataract Refract Surg. 2015 Sep;41(9):1810-9. doi: 10.1016/j.jcrs.2015.10.007. — View Citation

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. doi: 10.1155/2015/514837. — View Citation

Shaheen MS, Shalaby Bardan A, Piñero DP, Ezzeldin H, El-Kateb M, Helaly H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a High-Resolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus. Cornea. 2016 Jul;35(7):946-53. doi: 10.1097/ICO.0000000000000888. — View Citation

Sinha Roy A, Kurian M, Matalia H, Shetty R. Air-puff associated quantification of non-linear biomechanical properties of the human cornea in vivo. J Mech Behav Biomed Mater. 2015 Aug;48:173-82. doi: 10.1016/j.jmbbm.2015.04.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity measured as Logarithm of manifest refraction	Uncorrected and corrected distance visual acuity	Post surgery over a period of 1 year	No
Secondary	Change in Corneal curvature in Diopter	Optical coherence tomography and Scheimpflug imaging of the cornea will be performed	Post surgery over a period of 1 year	No
Secondary	Change in deformation of the cornea	Air-puff applanation of the cornea will be used to asses deformation	Post surgery over a period of 1 year	No
Secondary	Change in ocular surface dryness and/or pain	Assessed by ocular surface discomfort score	Post surgery over a period of 1 year	No
Secondary	Change in wavefront aberrations described by Zernike Polynomials	Corneal and ocular aberrations	Post surgery over a period of 1 year	No