MyopiaNCT05611294
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
A study testing Topography Guided LASIK Surgery and Small Incision Lenticule Extraction Surgery in people with Myopia and Astigmatism, run by Hoopes Vision at 1 site in United States.
Trial summary
This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Topography Guided LASIK Surgery and Small Incision Lenticule Extraction Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 1 Jun 2025
- 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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 22-50 at the time of consent
- Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D
- Preop Spherical component of ≥ -2.00 and ≤ -8.00 D
- Refractive Cylinder of ≤ -3.00 D
- BCVA of 20/20 or better in each eye
- Subjects must have a stable refraction which is defined as change in spherical equivalent no greater than 0.50 D comparing screening visit manifest refraction to previous refractions over one year period prior to surgery. (spectacle Rx, or contact lens Rx)
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- Subjects who are contact lens wearers must have hard or gas permeable lenses discontinued for at least 4 weeks and soft lenses discontinued for at least 5 days prior to the preoperative screening evaluation. Hard or gas permeable lens wearers must not return to contact lens use before surgery and soft lens wearers must discontinue use at least 5 days before surgery.
- Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator
- Surgical plan includes treatment target for emmetropia in both eyes and no monovision.
- Subject is capable and willing to use postoperative medications as prescribed.
- Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
- Subjects are willing and able to return for all postoperative examinations.
Who cannot join
- Clinically significant dry eye on clinical examination as determined by the investigator
- Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography
- History of corneal dystrophies or guttata
- History of herpetic keratitis or active disease
- History of prior refractive surgery
- History of glaucoma or glaucoma suspect
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- History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
- Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry.
- The Principal Investigator has determined the subject not to be a good candidate for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Visual Outcome Comparison of Topography Guided LASIK Versus Small Incision Lenticule Extraction: A Prospective Contralateral Eye Study
This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.
Read the detailed description
This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.
- Conditions
- Myopia, Astigmatism
- Being tested
- Topography Guided LASIK Surgery, Small Incision Lenticule Extraction Surgery
- Keywords
- refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, VARIO Topolyzer, Lenticule
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topography Guided LASIK SurgeryDevice
LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error.
Small Incision Lenticule Extraction SurgeryDevice
Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error.
| Study group | Role | What they receive |
|---|---|---|
| Topography-Guided LASIK | Active comparator | Subjects receive Topography-Guided LASIK surgery on one eye. Receives: Device: Topography Guided LASIK Surgery |
| Small Incision Lenticule Extraction | Active comparator | Subjects receive Small Incision Lenticule Extraction surgery on one eye. Receives: Device: Small Incision Lenticule Extraction Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity
Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better
Measured: 12 months
Corrected Visual Acuity
Percentage of eyes with Corrected Visual Acuity of 20/20 or better
Measured: 12 months
Secondary outcomes (1)
Predictability of Intended Outcome
Percentage of eyes with refractive error within +/- 0.50 D MRSE and +/- 1.00 D MRSE of intended correction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start27 Sep 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
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
- Contralateral Eye to Eye Comparison
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoopes Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Majid Moshirfar, MD, Principal investigator, Hoopes Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611294
- Sponsor's protocol ID
- HDRR-CON2022
- Status last verified
- Jul 2024
- First submitted
- 27 Oct 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared with other researchers outside of those participating in this specific study.
Publications
Moin KA, Manion GN, Pandiri S, Hoopes PC, Moshirfar M. Three-Month Comprehensive Outcomes of Topography-Guided LASIK Versus Keratorefractive Lenticule Extraction (KLEx): A Prospective Contralateral Study. Ophthalmol Ther. 2024 Aug;13(8):2265-2284. doi: 10.1007/s40123-024-00987-y. Epub 2024 Jul 1.
PubMed 38951314
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Visual Outcome Comparison of Topography Guided LASIK Versus Small Incision Lenticule Extraction: A Prospective Contralateral Eye Study
- ClinicalTrials.gov ID
- NCT05611294
- Acronym / sponsor ID
- HDRR-CON2022
- Conditions
- Myopia, Astigmatism
- Keywords
- refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, VARIO Topolyzer, Lenticule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hoopes VisionUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Nov 2022 (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.
This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.
Detailed description
This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Contralateral Eye to Eye Comparison
| Arm | Type | Receives |
|---|---|---|
| Topography-Guided LASIK | Active comparator | Device: Topography Guided LASIK SurgerySubjects receive Topography-Guided LASIK surgery on one eye. |
| Small Incision Lenticule Extraction | Active comparator | Device: Small Incision Lenticule Extraction SurgerySubjects receive Small Incision Lenticule Extraction surgery on one eye. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 22-50 at the time of consent
- Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D
- Preop Spherical component of ≥ -2.00 and ≤ -8.00 D
- Refractive Cylinder of ≤ -3.00 D
- BCVA of 20/20 or better in each eye
Key exclusion criteria (9 listed)
- Clinically significant dry eye on clinical examination as determined by the investigator
- Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography
- History of corneal dystrophies or guttata
- History of herpetic keratitis or active disease
- History of prior refractive surgery
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 |
|---|---|---|
| Topography Guided LASIK SurgeryLASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error. | Device | Topography-Guided LASIK |
| Small Incision Lenticule Extraction SurgeryCorneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error. | Device | Small Incision Lenticule Extraction |
Primary outcome
Uncorrected Visual Acuity
Time frame: 12 months
Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better
Corrected Visual Acuity
Time frame: 12 months
Percentage of eyes with Corrected Visual Acuity of 20/20 or better
1 secondary outcome
Predictability of Intended Outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 38951314Moin KA, Manion GN, Pandiri S, Hoopes PC, Moshirfar M. Three-Month Comprehensive Outcomes of Topography-Guided LASIK Versus Keratorefractive Lenticule Extraction (KLEx): A Prospective Contralateral Study. Ophthalmol Ther. 2024 Aug;13(8):2265-2284. doi: 10.1007/s40123-024-00987-y. Epub 2024 Jul 1.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers outside of those participating in this specific study.
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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.
Majid Moshirfar, MD principal investigator
Hoopes Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topography Guided LASIK Surgery and Small Incision Lenticule Extraction Surgery in people with Myopia and Astigmatism, run by Hoopes Vision 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 12 inclusion and 9 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 1 Aug 2024. 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?
Results are not available in the source record.
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?
Uncorrected Visual Acuity (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05611294, 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 1 Aug 2024.