MyopiaPhase 4NCT03001401
Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE
A Phase 4 study testing iDesign and SMILE in people with Myopia, run by Narayana Nethralaya at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- iDesign and SMILE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Narayana Nethralaya
Bangalore, Karnataka, 560010
Rohit Shetty, MD, PhD, +919611102568, drrohitshetty@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- iDesign, SMILE
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| iDesign | Active comparator | Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power Receives: Other: iDesign |
| SMILE | Active comparator | Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power Receives: Other: SMILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity measured as Logarithm of manifest refraction
Uncorrected and corrected distance visual acuity
Measured: Post surgery over a period of 1 year
Secondary outcomes (4)
Change in Corneal curvature in Diopter
Optical coherence tomography and Scheimpflug imaging of the cornea will be performed
Measured: Post surgery over a period of 1 year
Change in deformation of the cornea
Air-puff applanation of the cornea will be used to asses deformation
Measured: Post surgery over a period of 1 year
Change in ocular surface dryness and/or pain
Assessed by ocular surface discomfort score
Measured: Post surgery over a period of 1 year
Change in wavefront aberrations described by Zernike Polynomials
Corneal and ocular aberrations
Measured: Post surgery over a period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Narayana Nethralaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rohit Shetty, Narayana Nethralaya
- Investigators
- Rohit Shetty, MD, PHD, Principal investigator, Narayana Nethralaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001401
- Sponsor's protocol ID
- C/2016/09/07
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26603388Schallhorn 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.
PubMed 26504595Shaheen 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.
PubMed 27191671Denoyer 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.
PubMed 25458707Reinstein 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.
PubMed 26605350McNabb 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.
PubMed 25487424Matalia 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.
PubMed 27400081Sinha 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.
PubMed 25955559
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE
- ClinicalTrials.gov ID
- NCT03001401
- Acronym / sponsor ID
- C/2016/09/07
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Narayana NethralayaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iDesign | Active comparator | Other: iDesignEyes will under LASIK using iDesign platform for treatment of sphere and cylinder power |
| SMILE | Active comparator | Other: SMILEEyes will under SMILE using Visumax platform for treatment of sphere and cylinder power |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDesignOne 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. | Other | iDesign |
| SMILEThe 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. | Other | SMILE |
Primary outcome
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
4 secondary outcomes
Change in Corneal curvature in Diopter
Time frame: Post surgery over a period of 1 year
Change in deformation of the cornea
Time frame: Post surgery over a period of 1 year
Change in ocular surface dryness and/or pain
Time frame: Post surgery over a period of 1 year
Change in wavefront aberrations described by Zernike Polynomials
Time frame: Post surgery over a period of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Background: PubMed 26603388Schallhorn 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.
- Background: PubMed 26504595Schallhorn 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.
- Background: PubMed 27191671Shaheen 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.
- Background: PubMed 25458707Denoyer 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.
- Background: PubMed 26605350Reinstein 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.
- Background: PubMed 25487424McNabb 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.
- Background: PubMed 27400081Matalia 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.
- Background: PubMed 25955559Sinha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Shetty, MD, PHD principal investigator
Narayana Nethralaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iDesign and SMILE in people with Myopia, run by Narayana Nethralaya at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abhijit Sinha Roy, PhD (+919740566833, asroy27@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity measured as Logarithm of manifest refraction (time frame: Post surgery over a period of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03001401, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.