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

Primary Purpose

Myopia

Status

Unknown status

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

iDesign

SMILE

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Narayana NethralayaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

iDesign

SMILE

Arm Description

Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power

Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power

Outcomes

Primary Outcome Measures

Change in visual acuity measured as Logarithm of manifest refraction

Uncorrected and corrected distance visual acuity

Secondary Outcome Measures

Change in Corneal curvature in Diopter

Optical coherence tomography and Scheimpflug imaging of the cornea will be performed

Change in deformation of the cornea

Air-puff applanation of the cornea will be used to asses deformation

Change in ocular surface dryness and/or pain

Assessed by ocular surface discomfort score

Change in wavefront aberrations described by Zernike Polynomials

Corneal and ocular aberrations

Full Information

NCT ID

NCT03001401

First Posted

December 15, 2016

Last Updated

December 19, 2016

Sponsor

Narayana Nethralaya

1. Study Identification

Unique Protocol Identification Number

NCT03001401

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Narayana Nethralaya

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

iDesign

Arm Type

Active Comparator

Arm Description

Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power

Arm Title

SMILE

Arm Type

Active Comparator

Arm Description

Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power

Intervention Type

Other

Intervention Name(s)

iDesign

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

SMILE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in visual acuity measured as Logarithm of manifest refraction

Description

Uncorrected and corrected distance visual acuity

Time Frame

Post surgery over a period of 1 year

Secondary Outcome Measure Information:

Title

Change in Corneal curvature in Diopter

Description

Optical coherence tomography and Scheimpflug imaging of the cornea will be performed

Time Frame

Post surgery over a period of 1 year

Title

Change in deformation of the cornea

Description

Air-puff applanation of the cornea will be used to asses deformation

Time Frame

Post surgery over a period of 1 year

Title

Change in ocular surface dryness and/or pain

Description

Assessed by ocular surface discomfort score

Time Frame

Post surgery over a period of 1 year

Title

Change in wavefront aberrations described by Zernike Polynomials

Description

Corneal and ocular aberrations

Time Frame

Post surgery over a period of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abhijit Sinha Roy, PhD

Phone

+919740566833

asroy27@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rohit Shetty, MD, PHD

Organizational Affiliation

Narayana Nethralaya

Official's Role

Principal Investigator

Facility Information:

Facility Name

Narayana Nethralaya

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560010

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rohit Shetty, MD, PhD

Phone

+919611102568

drrohitshetty@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26603388

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.

Results Reference

background

PubMed Identifier

26504595

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. Epub 2015 Oct 4.

Results Reference

background

PubMed Identifier

27191671

Citation

Shaheen MS, Shalaby Bardan A, Pinero 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.

Results Reference

background

PubMed Identifier

25458707

Citation

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. Epub 2014 Nov 22.

Results Reference

background

PubMed Identifier

26605350

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. eCollection 2014.

Results Reference

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PubMed Identifier

25487424

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. Epub 2014 Dec 6.

Results Reference

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PubMed Identifier

27400081

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.

Results Reference

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PubMed Identifier

25955559

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;48:173-182. doi: 10.1016/j.jmbbm.2015.04.010. Epub 2015 Apr 20.

Results Reference

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

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