MyopiaTG-LASIK vs SMNCT07126756
LASIK iDesign vs SMILE
A study testing STAR S4 IR Excimer Laser System and VisuMax 400 Surgical Laser in people with Myopia and Astigmatism, run by 59th Medical Wing at 1 site in United States.
Trial summary
The study will compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, higher order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using iDesign and SMILE surgery. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- STAR S4 IR Excimer Laser System and VisuMax 400 Surgical Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nearsightedness (myopia) between -2.00 diopters and -8.00 diopters
- Have similar levels of nearsightedness in each eye (2D or less difference between eyes)
- Less than or equal to 3.00 diopters of astigmatism
- Total spherical equivalent (SE) of no more than -8.0 D
- Tricare Prime/Select Beneficiary (military health insurance)
- Residing within 60 miles radius from Lackland AFB
Who cannot join
- Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and volunteers whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (um) of corneal stroma from the corneal endothelium.
- Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
- Pregnant or nursing females (pregnancy test will be performed on females subjects of childbearing potential)
- Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy
- Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection.
- 0.25 or 0.50 of manifest astigmatism in the eye randomized to SMILE
- Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.
- Potential candidate who cannot provide Informed Consent will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78009
About this study
Official title: Visual Outcomes Comparison of LASIK Using Wavefront Optimized and SMILE
The study will compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, higher order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using iDesign and SMILE surgery.
Read the detailed description
Both SMILE and LASIK treatments are FDA-approved and are both performed routinely as standard of care surgery in the US Military. However, there is limited literature comparing quality of vision after LASIK using iDesign and SMILE refractive surgery. Our objective is to study the 6-month visual outcomes (high and 5% low contrast visual acuity, refractive error, higher order aberrations) and subject reported quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms using the PROWL and SPEED questionnaires following contralateral LASIK using iDesign and SMILE surgery. This is a prospective randomized contralateral study, including 57 subjects. Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using iDesign on the contralateral eye to correct myopia. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at day 1, week 2, month 1, month 3, and month 6.
- Conditions
- Myopia, Astigmatism
- Being tested
- STAR S4 IR Excimer Laser System, VisuMax 400 Surgical Laser
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR S4 IR Excimer Laser SystemDevice
Also called iDesign Refractive Studio
LASIK with iDesign
VisuMax 400 Surgical LaserDevice
small incision lenticule extraction technique
| Study group | Role | What they receive |
|---|---|---|
| LASIK using iDesign | Active comparator | LASIK guided by iDesign Receives: Device: STAR S4 IR Excimer Laser System |
| SMILE | Experimental | SMILE Refractive Surgery Receives: Device: VisuMax 400 Surgical Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Uncorrected Visual Acuity of 20/16 or Better at 6-month Post-Op
Post-operative uncorrected visual acuity of 20/16 or better measure using the ETDRS chart reported as percentage of subjects; unit = percentage eyes with Uncorrected Visual Acuity
Measured: 6-month Post-Op
Secondary outcomes (6)
Difference in High Contrast Visual Acuity at 6-month Post-Op
Mean uncorrected high contrast visual acuity measure using the ETDRS chart measure at 6-month Post-Op; unit = LogMAR
Measured: 6-month Post-Op
Difference in residual Refractive Error at 6-month Post-Op
Residual mean refractive error measure with phoropter at 6-month Post-Op; unit = Diopters (D)
Measured: 6-month Post-Op
Difference in Low Contrast Visual Acuity at 6-month Post-Op
Mean uncorrected low contrast visual acuity measure using the 5% ETDRS chart measure at 6-month Post-Op; unit = LogMAR
Measured: 6-month Post-Op
Difference in residual Higher Order Aberrations at 6-month Post-Op
Mean Higher Order Aberrations measure by iDesign 2.0 Refractive Studio at 6-month Post-Op; unit = root mean square
Measured: 6-month Post-Op
Difference in overall satisfaction questionnaire score at 6-month Post-Op
Mean Subject Satisfaction Score with the surgery outcome using the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op. The score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction.
Measured: 6-month Post-Op
Difference in overall Dry Eye questionnaire score at 6-month Post-Op
Mean Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire score at 6-month Post-Op. Possible dry eye symptoms score ranges from 0 (never) to 3 (Constant). Higher value indicates worse dry eye symptoms.
Measured: 6-month Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start10 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized contralateral study
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- United States Army Aeromedical Research Laboratory
- Responsible party
- Sponsor
- Investigators
- Charisma B Evangelista, MD, Principal investigator, Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126756
- Sponsor's protocol ID
- C.2024.066
- Acronym
- TG-LASIK vs SM
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.
PubMed 36539217Bharti S, Bains HS. Active cyclotorsion error correction during LASIK for myopia and myopic astigmatism with the NIDEK EC-5000 CX III laser. J Refract Surg. 2007 Nov;23(9 Suppl):S1041-5. doi: 10.3928/1081-597X-20071102-11.
PubMed 18047004
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes Comparison of LASIK Using Wavefront Optimized and SMILE
- ClinicalTrials.gov ID
- NCT07126756
- Acronym / sponsor ID
- TG-LASIK vs SM / C.2024.066
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- 59th Medical WingUS federal agency
- Collaborators
- United States Army Aeromedical Research Laboratory
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- 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 study will compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, higher order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using iDesign and SMILE surgery.
Detailed description
Both SMILE and LASIK treatments are FDA-approved and are both performed routinely as standard of care surgery in the US Military. However, there is limited literature comparing quality of vision after LASIK using iDesign and SMILE refractive surgery. Our objective is to study the 6-month visual outcomes (high and 5% low contrast visual acuity, refractive error, higher order aberrations) and subject reported quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms using the PROWL and SPEED questionnaires following contralateral LASIK using iDesign and SMILE surgery. This is a prospective randomized contralateral study, including 57 subjects. Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using iDesign on the contralateral eye to correct myopia. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at day 1, week 2, month 1, month 3, and month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized contralateral study
| Arm | Type | Receives |
|---|---|---|
| LASIK using iDesign | Active comparator | Device: STAR S4 IR Excimer Laser SystemLASIK guided by iDesign |
| SMILE | Experimental | Device: VisuMax 400 Surgical LaserSMILE Refractive Surgery |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Nearsightedness (myopia) between -2.00 diopters and -8.00 diopters
- Have similar levels of nearsightedness in each eye (2D or less difference between eyes)
- Less than or equal to 3.00 diopters of astigmatism
- Total spherical equivalent (SE) of no more than -8.0 D
- Tricare Prime/Select Beneficiary (military health insurance)
Key exclusion criteria (8 listed)
- Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and volunteers whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (um) of corneal stroma from the corneal endothelium.
- Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
- Pregnant or nursing females (pregnancy test will be performed on females subjects of childbearing potential)
- Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy
- Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection.
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 |
|---|---|---|
| STAR S4 IR Excimer Laser SystemAlso: iDesign Refractive StudioLASIK with iDesign | Device | LASIK using iDesign |
| VisuMax 400 Surgical Lasersmall incision lenticule extraction technique | Device | SMILE |
Primary outcome
Percentage of Eyes With Uncorrected Visual Acuity of 20/16 or Better at 6-month Post-Op
Time frame: 6-month Post-Op
Post-operative uncorrected visual acuity of 20/16 or better measure using the ETDRS chart reported as percentage of subjects; unit = percentage eyes with Uncorrected Visual Acuity
6 secondary outcomes
Difference in High Contrast Visual Acuity at 6-month Post-Op
Time frame: 6-month Post-Op
Difference in residual Refractive Error at 6-month Post-Op
Time frame: 6-month Post-Op
Difference in Low Contrast Visual Acuity at 6-month Post-Op
Time frame: 6-month Post-Op
Difference in residual Higher Order Aberrations at 6-month Post-Op
Time frame: 6-month Post-Op
Difference in overall satisfaction questionnaire score at 6-month Post-Op
Time frame: 6-month Post-Op
Difference in overall Dry Eye questionnaire score at 6-month Post-Op
Time frame: 6-month Post-Op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 36539217Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.
- Background: PubMed 18047004Bharti S, Bains HS. Active cyclotorsion error correction during LASIK for myopia and myopic astigmatism with the NIDEK EC-5000 CX III laser. J Refract Surg. 2007 Nov;23(9 Suppl):S1041-5. doi: 10.3928/1081-597X-20071102-11.
- Individual participant dataSharing planned: No
Related trials for Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Not yet recruiting
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
High Myopia
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.
Charisma B Evangelista, MD principal investigator
Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR S4 IR Excimer Laser System and VisuMax 400 Surgical Laser in people with Myopia and Astigmatism, run by 59th Medical Wing at 1 site in United States.
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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eyes With Uncorrected Visual Acuity of 20/16 or Better at 6-month Post-Op (time frame: 6-month Post-Op). 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 NCT07126756, which also lists 2 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 17 Aug 2025.