MyopiaNCT03292419
Topography-guided LASIK Surgery
A study testing Topography-guided LASIK in people with Myopia, run by Stanford University at 1 site in United States.
Trial summary
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Topography-guided LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Mar 2022
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
- Subjects with up to 3.00 diopters of astigmatism.
- Subjects with a spherical equivalent of up to -9.00 diopters.
Who cannot join
- Subjects under the age of 18.
- Subjects with excessively thin corneas.
- Subjects with topographic evidence of keratoconus.
- Subjects with ectatic eye disorders.
- Subjects with autoimmune diseases.
- Subjects who are pregnant or nursing.
- Subjects with more than 3.00 diopters of astigmatism
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
Official title: A Prospective Evaluation of Topography-guided LASIK Surgery
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism
Read the detailed description
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time
- Conditions
- Myopia
- Being tested
- Topography-guided LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topography-guided LASIKProcedure or surgery
LASIK surgery
| Study group | Role | What they receive |
|---|---|---|
| Topography guided LASI | Other | Not described Receives: Procedure: Topography-guided LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial thickness maps
Changes in anterior segment optical coherence tomography epithelial thickness maps.
Measured: 12 months
Secondary outcomes (7)
Changes in corrected visual acuity
Corrected distance visual acuity (CDVA)
Measured: 12 months
Uncorrected distance visual acuity
Uncorrected distance visual acuity (UDVA)
Measured: 12 months
Quality of Vision
Patient reported outcomes questionnaire
Measured: 12 months
Predictability
Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction
Measured: 12 months
Contrast visual acuity
5 and 25% ETDRS contrast acuity
Measured: 12 months
Residual astigmatism levels after surgery
Vector analysis of astigmatic outcomes
Measured: 12 months
Change in refraction over time
Change in spherical equivalent over time
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 posted25 Sep 2017
- Study start1 Jun 2018
- Primary completion30 Jun 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Topography guided
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E Manche, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292419
- Sponsor's protocol ID
- 43306
- Status last verified
- Apr 2022
- First submitted
- 18 Sep 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Topography-guided LASIK Surgery
- ClinicalTrials.gov ID
- NCT03292419
- Acronym / sponsor ID
- 43306
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Sep 2017 (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 investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism
Detailed description
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Topography guided
| Arm | Type | Receives |
|---|---|---|
| Topography guided LASI | Other | Procedure: Topography-guided LASIK |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
- Subjects with up to 3.00 diopters of astigmatism.
- Subjects with a spherical equivalent of up to -9.00 diopters.
Key exclusion criteria (7 listed)
- Subjects under the age of 18.
- Subjects with excessively thin corneas.
- Subjects with topographic evidence of keratoconus.
- Subjects with ectatic eye disorders.
- Subjects with autoimmune diseases.
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 LASIKLASIK surgery | Procedure or surgery | Topography guided LASI |
Primary outcome
Epithelial thickness maps
Time frame: 12 months
Changes in anterior segment optical coherence tomography epithelial thickness maps.
7 secondary outcomes
Changes in corrected visual acuity
Time frame: 12 months
Uncorrected distance visual acuity
Time frame: 12 months
Quality of Vision
Time frame: 12 months
Predictability
Time frame: 12 months
Contrast visual acuity
Time frame: 12 months
Residual astigmatism levels after surgery
Time frame: 12 months
Change in refraction over time
Time frame: 12 months
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 5 Apr 2022.
- 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.
Edward E Manche, MD principal investigator
Stanford University
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 in people with Myopia, run by Stanford University 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 3 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 5 Apr 2022. 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?
Epithelial thickness maps (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.