NCT03001401

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 15, 2016

Last Update Submit

December 19, 2016

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Change in visual acuity measured as Logarithm of manifest refraction

    Uncorrected and corrected distance visual acuity

    Post surgery over a period of 1 year

Secondary Outcomes (4)

  • 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

Study Arms (2)

iDesign

ACTIVE COMPARATOR

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

Other: iDesign

SMILE

ACTIVE COMPARATOR

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

Other: SMILE

Interventions

iDesignOTHER

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.

iDesign
SMILEOTHER

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.

SMILE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narayana Nethralaya

Bangalore, Karnataka, 560010, India

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26603388BACKGROUND

  • 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.

    PMID: 26504595BACKGROUND

  • 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.

    PMID: 27191671BACKGROUND

  • 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.

    PMID: 25458707BACKGROUND

  • 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.

    PMID: 26605350BACKGROUND

  • 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.

    PMID: 25487424BACKGROUND

  • 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.

    PMID: 27400081BACKGROUND

  • 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.

    PMID: 25955559BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Rohit Shetty, MD, PHD

    Narayana Nethralaya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhijit Sinha Roy, PhD

CONTACT

+919740566833asroy27@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 23, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 23, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)