MyopiaNCT05844397
SMILE vs. LASIK Using Contoura With Phorcides
A study testing WaveLight EX500 Excimer Laser System and VisuMax Surgical Laser in people with Myopia and Astigmatism, run by 59th Medical Wing at 1 site in United States.
Trial summary
Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia. 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?
- WaveLight EX500 Excimer Laser System and VisuMax Surgical Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 14 May 2024
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Females between the ages of 21 and 50
- Nearsightedness between -2.00 diopters and -8.00 diopters
- Have similar levels of nearsightedness in each eye (≤1.5D of difference between eyes)
- Less than or equal to 3.00 diopters of astigmatism
- Have similar levels of astigmatism in each eye (≤0.75D of difference between eyes)
- Total spherical equivalent (SE) of no more than -8.0 D
- Tricare Prime Beneficiary
- 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 patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium.
- Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
- Pregnant or nursing females
- 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 either eye
- Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Joint Warfighter Refractive Surgery Center at WHASC
San Antonio, Texas, 78236
About this study
Official title: Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides
Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.
Read the detailed description
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 Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. 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 week 2, month 1, month 3, and month 6.
- Conditions
- Myopia, Astigmatism
- Being tested
- WaveLight EX500 Excimer Laser System, VisuMax Surgical Laser
- Keywords
- SMILE, LASIK, Countoura, Phorcides
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveLight EX500 Excimer Laser SystemDevice
LASIK Refractive Surgery Using Contura with Phorcides
VisuMax Surgical LaserDevice
SMILE Refractive Surgery
| Study group | Role | What they receive |
|---|---|---|
| LASIK using Contoura with Phorcides | Active comparator | LASIK using Contoura with Phorcides in one eye. Receives: Device: WaveLight EX500 Excimer Laser System |
| SMILE | Active comparator | small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye. Receives: Device: VisuMax 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 with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity
Measured: 6-month Post-Op
Secondary outcomes (2)
Change in high contrast visual acuity at 6-month Post-Op
Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 6 months post-op.
Measured: Change from baseline (pre-op) to 6-month Post-Op
Change in refractive error at 6-month Post-Op
Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 6 months post-op.
Measured: Change from baseline (pre-op) to 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 posted6 May 2023
- Study start9 May 2023
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Charisma B Evangelista, MD, Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844397
- Sponsor's protocol ID
- C.2023.052
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2023
- Last updated
- 27 Feb 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 36539217
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides
- ClinicalTrials.gov ID
- NCT05844397
- Acronym / sponsor ID
- C.2023.052
- Conditions
- Myopia, Astigmatism
- Keywords
- SMILE, LASIK, Countoura, Phorcides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- 9 May 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 6 May 2023 (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.
Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.
Detailed description
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 Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. 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 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 Contoura with Phorcides | Active comparator | Device: WaveLight EX500 Excimer Laser SystemLASIK using Contoura with Phorcides in one eye. |
| SMILE | Active comparator | Device: VisuMax Surgical Lasersmall incision lenticule extraction (SMILE) refractive surgery on the contralateral eye. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and Females between the ages of 21 and 50
- Nearsightedness between -2.00 diopters and -8.00 diopters
- Have similar levels of nearsightedness in each eye (≤1.5D of difference between eyes)
- Less than or equal to 3.00 diopters of astigmatism
- Have similar levels of astigmatism in each eye (≤0.75D of difference between eyes)
Key exclusion criteria (7 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 patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium.
- Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
- Pregnant or nursing females
- 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 |
|---|---|---|
| WaveLight EX500 Excimer Laser SystemLASIK Refractive Surgery Using Contura with Phorcides | Device | LASIK using Contoura with Phorcides |
| VisuMax Surgical LaserSMILE Refractive Surgery | 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 with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity
2 secondary outcomes
Change in high contrast visual acuity at 6-month Post-Op
Time frame: Change from baseline (pre-op) to 6-month Post-Op
Change in refractive error at 6-month Post-Op
Time frame: Change from baseline (pre-op) to 6-month Post-Op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
Charisma B Evangelista, MD principal investigator
59th Medical Wing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WaveLight EX500 Excimer Laser System and VisuMax 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 8 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: finished, as of the sponsor's last update on 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT05844397, which also lists 1 linked publication.
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 27 Feb 2025.