Optical Coherence TomographyNCT05856786
To Study the Effects of Refractive Surgery on OCT Measurements in the Eye
An observational study of Optical Coherence Tomography and Refractive Errors, run by University of Nebraska at 1 site in United States.
Trial summary
Corrective eye surgeries, such as Lasik, are widely used to correct focusing problems such as myopia, or nearsightedness. Often these patients develop other conditions like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Optical Coherence Tomography, Refractive Errors, Myopia
- What is being tested?
- Optical coherence tomography
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Dec 2027
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects in the study will be adults aged 19 years or more, that fits the typical age profile of patients in the refractive surgery clinic. Refractive surgery is an elective surgery and the patients are encouraged to ask questions about the study. This is an observational study and all aspects of care, including procedures, visits, and exams, carried out as part of the study represent standard of care. Patients visiting the refractive surgery clinic will be given an option to participate in the study if they meet the selection criteria. The clinical care of the patient will not be affected by the patient's participation or non-participation in the study.
Who may be able to join
- Patients undergoing refractive surgery
- For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.
Who cannot join
- Astigmatism more than 3 Diopters
- Visual acuity worse than 20/25
- Patients with unstable visual fixation
- Severe Dry Eye
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68105
Pukhraj P Rishi, MBBS, 402-559-2020, pukhraj.rishi@unmc.edu
Lisa Reid, 402-559-1851, lisa.reid@unmc.edu
About this study
Official title: To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study
Corrective eye surgeries, such as Lasik, are widely used to correct focusing problems such as myopia, or nearsightedness. Often these patients develop other conditions like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes the refractive status of the eye (in the cornea or the lens), it can potentially affect the results of the OCT measurements but has not been sufficiently studied. This pilot study aims at studying the potential change in OCT parameters in the eye after undergoing such surgery.
Read the detailed description
Refractive surgeries are widely used in patients with ametropia. Refractive surgery is most commonly performed in patients with myopia. These patients often have a predilection for developing other conditions in the posterior segment of the eye, like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes in the refractive status of the eye (in the cornea or the lens) can potentially affect the results of the OCT measurements. Literature review reveals that the effect of significant changes in refractive power of the eye on the parameters of optical coherence tomography (OCT) has not been sufficiently studied. Some authors simulated the effect of refractive surgery using a contact lens but had diverging results. This prospective pilot study aims at studying the potential change in OCT parameters in the eye after undergoing refractive surgery.
- Conditions
- Optical Coherence Tomography, Refractive Errors, Myopia
- Being tested
- Optical coherence tomography
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDiagnostic test
Posterior segment OCT (a non-contact procedure performed over one minute) is additionally performed for patients participating in this study. Proportion of change in measurements in microns will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Ocular parameters | Patients aged 19 years or more who are scheduled to undergo refractive surgery will be included in the study. OCT will be performed at baseline (before surgery), 1 day after surgery and 1 week after surgery. Each patient will be tested 3 times. Receives: Diagnostic Test: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
Proportion of Change in thickness of retina and its layers measured in microns
Measured: 1 day after refractive procedure
Macular thickness
Proportion of Change in thickness of retina and its layers measured in microns
Measured: 1 week after refractive procedure
Secondary outcomes (10)
Choroidal thickness
Proportion of Change in thickness of choroid and its layers measured in microns
Measured: 1 day after refractive procedure
Choroidal thickness
Proportion of Change in thickness of choroid and its layers measured in microns
Measured: 1 week after refractive procedure
visual acuity
Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units
Measured: 1 day after refractive procedure
visual acuity
Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units
Measured: 1 week after refractive procedure
central corneal thickness
Proportion of Change in thickness of cornea measured in microns
Measured: 1 day after refractive procedure
central corneal thickness
Proportion of Change in thickness of cornea measured in microns
Measured: 1 week after refractive procedure
anterior chamber depth
Proportion of Change in depth of anterior chamber of the eye measured in microns
Measured: 1 day after refractive procedure
anterior chamber depth
Proportion of Change in depth of anterior chamber of the eye measured in microns
Measured: 1 week after refractive procedure
keratometry
Proportion of Change in corneal curvature measured in diopters
Measured: 1 day after refractive procedure
keratometry
Proportion of Change in corneal curvature measured in diopters
Measured: 1 week after refractive procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jun 2024
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Optical Coherence TomographyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pukhraj P Rishi, MBBS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856786
- Sponsor's protocol ID
- 0262-22-EP
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Liao H, Sun Y, Shen X. Short-term changes in the anterior segment and retina after small incision lenticule extraction. BMC Ophthalmol. 2020 Oct 7;20(1):397. doi: 10.1186/s12886-020-01668-7.
PubMed 33028265Shpak AA, Kostenev SV, Mushkova IA, Korobkova MV. [Effect of corneal refractive surgery on optical coherence tomography measurements]. Vestn Oftalmol. 2018;134(5):48-53. doi: 10.17116/oftalma201813405148. Russian.
PubMed 30499539Ozsaygili C, Altunel O, Duru N. Evaluation of the change in retinal thickness after femtosecond laser-assisted laser in situ keratomileusis and photorefractive keratectomy. Curr Eye Res. 2022 Jan;47(1):18-24. doi: 10.1080/02713683.2021.1951297. Epub 2021 Jul 7.
PubMed 34231433Yalcinkaya G, Yildiz BK, Cakir I, Yildirim Y, Demirok A. Evaluation of peripapillary - macular microvascularity and choroidal vascularity index after refractive surgery. Photodiagnosis Photodyn Ther. 2022 Mar;37:102714. doi: 10.1016/j.pdpdt.2022.102714. Epub 2022 Jan 5.
PubMed 34995787
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effects of Refractive Surgery on Optical Coherence Tomography (OCT) Measurements in the Eye: A Pilot Study
- ClinicalTrials.gov ID
- NCT05856786
- Acronym / sponsor ID
- 0262-22-EP
- Conditions
- Optical Coherence Tomography, Refractive Errors, Myopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 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.
Corrective eye surgeries, such as Lasik, are widely used to correct focusing problems such as myopia, or nearsightedness. Often these patients develop other conditions like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes the refractive status of the eye (in the cornea or the lens), it can potentially affect the results of the OCT measurements but has not been sufficiently studied. This pilot study aims at studying the potential change in OCT parameters in the eye after undergoing such surgery.
Detailed description
Refractive surgeries are widely used in patients with ametropia. Refractive surgery is most commonly performed in patients with myopia. These patients often have a predilection for developing other conditions in the posterior segment of the eye, like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes in the refractive status of the eye (in the cornea or the lens) can potentially affect the results of the OCT measurements. Literature review reveals that the effect of significant changes in refractive power of the eye on the parameters of optical coherence tomography (OCT) has not been sufficiently studied. Some authors simulated the effect of refractive surgery using a contact lens but had diverging results. This prospective pilot study aims at studying the potential change in OCT parameters in the eye after undergoing refractive surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocular parameters | – | Diagnostic Test: Optical coherence tomographyPatients aged 19 years or more who are scheduled to undergo refractive surgery will be included in the study. OCT will be performed at baseline (before surgery), 1 day after surgery and 1 week after surgery. Each patient will be tested 3 times. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects in the study will be adults aged 19 years or more, that fits the typical age profile of patients in the refractive surgery clinic. Refractive surgery is an elective surgery and the patients are encouraged to ask questions about the study. This is an observational study and all aspects of care, including procedures, visits, and exams, carried out as part of the study represent standard of care. Patients visiting the refractive surgery clinic will be given an option to participate in the study if they meet the selection criteria. The clinical care of the patient will not be affected by the patient's participation or non-participation in the study.
Key inclusion criteria (2 listed)
- Patients undergoing refractive surgery
- For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.
Key exclusion criteria (4 listed)
- Astigmatism more than 3 Diopters
- Visual acuity worse than 20/25
- Patients with unstable visual fixation
- Severe Dry Eye
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 |
|---|---|---|
| Optical coherence tomographyPosterior segment OCT (a non-contact procedure performed over one minute) is additionally performed for patients participating in this study. Proportion of change in measurements in microns will be analyzed. | Diagnostic test | Ocular parameters |
Primary outcome
Macular thickness
Time frame: 1 day after refractive procedure
Proportion of Change in thickness of retina and its layers measured in microns
Macular thickness
Time frame: 1 week after refractive procedure
Proportion of Change in thickness of retina and its layers measured in microns
10 secondary outcomes
Choroidal thickness
Time frame: 1 day after refractive procedure
Choroidal thickness
Time frame: 1 week after refractive procedure
visual acuity
Time frame: 1 day after refractive procedure
visual acuity
Time frame: 1 week after refractive procedure
central corneal thickness
Time frame: 1 day after refractive procedure
central corneal thickness
Time frame: 1 week after refractive procedure
anterior chamber depth
Time frame: 1 day after refractive procedure
anterior chamber depth
Time frame: 1 week after refractive procedure
keratometry
Time frame: 1 day after refractive procedure
keratometry
Time frame: 1 week after refractive procedure
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 26 Aug 2026.
- Background: PubMed 33028265Chen Y, Liao H, Sun Y, Shen X. Short-term changes in the anterior segment and retina after small incision lenticule extraction. BMC Ophthalmol. 2020 Oct 7;20(1):397. doi: 10.1186/s12886-020-01668-7.
- Background: PubMed 30499539Shpak AA, Kostenev SV, Mushkova IA, Korobkova MV. [Effect of corneal refractive surgery on optical coherence tomography measurements]. Vestn Oftalmol. 2018;134(5):48-53. doi: 10.17116/oftalma201813405148. Russian.
- Background: PubMed 34231433Ozsaygili C, Altunel O, Duru N. Evaluation of the change in retinal thickness after femtosecond laser-assisted laser in situ keratomileusis and photorefractive keratectomy. Curr Eye Res. 2022 Jan;47(1):18-24. doi: 10.1080/02713683.2021.1951297. Epub 2021 Jul 7.
- Background: PubMed 34995787Yalcinkaya G, Yildiz BK, Cakir I, Yildirim Y, Demirok A. Evaluation of peripapillary - macular microvascularity and choroidal vascularity index after refractive surgery. Photodiagnosis Photodyn Ther. 2022 Mar;37:102714. doi: 10.1016/j.pdpdt.2022.102714. Epub 2022 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Optical Coherence Tomography
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
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.
Pukhraj P Rishi, MBBS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optical Coherence Tomography and Refractive Errors, run by University of Nebraska 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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?
Contact Pukhraj P Rishi, MBBS (402-559-2020, pukhraj.rishi@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular thickness (time frame: 1 day after refractive procedure). 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 NCT05856786, which also lists 4 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 26 Aug 2026.