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

NCT ID: NCT03001401

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iDesign

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

Group Type ACTIVE_COMPARATOR

iDesign

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

SMILE

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Narayana Nethralaya

OTHER

Sponsor Role lead

Responsible Party

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Dr Rohit Shetty

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rohit Shetty, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Narayana Nethralaya

Locations

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Narayana Nethralaya

Bangalore, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Abhijit Sinha Roy, PhD

Role: CONTACT

Phone: +919740566833

Email: [email protected]

Facility Contacts

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Rohit Shetty, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26603388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26504595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27191671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25458707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26605350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25487424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27400081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25955559 (View on PubMed)

Other Identifiers

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C/2016/09/07

Identifier Type: -

Identifier Source: org_study_id