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
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.
- 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