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

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ClinicalTrials.gov Identifier: NCT03001401
Recruitment Status : Unknown
Verified December 2016 by Dr Rohit Shetty, Narayana Nethralaya.
Recruitment status was:  Recruiting
First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Rohit Shetty, Narayana Nethralaya

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.

Condition or disease Intervention/treatment Phase
Myopia Other: iDesign Other: SMILE Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE
Study Start Date : November 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: iDesign
Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power
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.

Active Comparator: SMILE
Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power
Other: 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.




Primary Outcome Measures :
  1. Change in visual acuity measured as Logarithm of manifest refraction [ Time Frame: Post surgery over a period of 1 year ]
    Uncorrected and corrected distance visual acuity


Secondary Outcome Measures :
  1. Change in Corneal curvature in Diopter [ Time Frame: Post surgery over a period of 1 year ]
    Optical coherence tomography and Scheimpflug imaging of the cornea will be performed

  2. Change in deformation of the cornea [ Time Frame: Post surgery over a period of 1 year ]
    Air-puff applanation of the cornea will be used to asses deformation

  3. Change in ocular surface dryness and/or pain [ Time Frame: Post surgery over a period of 1 year ]
    Assessed by ocular surface discomfort score

  4. Change in wavefront aberrations described by Zernike Polynomials [ Time Frame: Post surgery over a period of 1 year ]
    Corneal and ocular aberrations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001401


Contacts
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Contact: Abhijit Sinha Roy, PhD +919740566833 asroy27@yahoo.com

Locations
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India
Narayana Nethralaya Recruiting
Bangalore, Karnataka, India, 560010
Contact: Rohit Shetty, MD, PhD    +919611102568    drrohitshetty@yahoo.com   
Sponsors and Collaborators
Narayana Nethralaya
Investigators
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Principal Investigator: Rohit Shetty, MD, PHD Narayana Nethralaya

Publications:

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Responsible Party: Dr Rohit Shetty, Doctor, Narayana Nethralaya
ClinicalTrials.gov Identifier: NCT03001401    
Other Study ID Numbers: C/2016/09/07
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases