ClinicalTrials.gg
RecruitingNCT05856786Updated Aug 26, 2026

To Study the Effects of Refractive Surgery on OCT Measurements in the Eye

An observational study in Optical Coherence Tomography, Refractive Errors and Myopia, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Primary conditionMyopiaRegistry: Refractive ErrorsReclassifiedWhy we changed it
Registry
Refractive Errors — the first condition term the registry derived for this study.
ClinicalTrials.gg
Myopia
Why
  1. The study's listed conditions name Myopia, a narrower term within Refractive Errors.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Nebraska · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33
Ages
19 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Optical Coherence Tomography
  • Refractive Errors
  • Myopia

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03

In context

Myopia Reclassified

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 33 is below the median of 150 across 204 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.

Compared within Myopia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Refractive Errors. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients undergoing refractive surgery
  2. For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.

Exclusion criteria

Exclusion Criteria:

  1. Astigmatism more than 3 Diopters
  2. Visual acuity worse than 20/25
  3. Patients with unstable visual fixation
  4. Severe Dry Eye
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Optical coherence tomography

Interventions

  • Diagnostic testOptical coherence tomography

    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.

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What researchers measure

Primary outcomes

  1. Macular thickness

    Proportion of Change in thickness of retina and its layers measured in microns

    Time frame: 1 day after refractive procedure

  2. Macular thickness

    Proportion of Change in thickness of retina and its layers measured in microns

    Time frame: 1 week after refractive procedure

Secondary outcomes

  1. Choroidal thickness

    Proportion of Change in thickness of choroid and its layers measured in microns

    Time frame: 1 day after refractive procedure

  2. Choroidal thickness

    Proportion of Change in thickness of choroid and its layers measured in microns

    Time frame: 1 week after refractive procedure

  3. visual acuity

    Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units

    Time frame: 1 day after refractive procedure

  4. visual acuity

    Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units

    Time frame: 1 week after refractive procedure

  5. central corneal thickness

    Proportion of Change in thickness of cornea measured in microns

    Time frame: 1 day after refractive procedure

  6. central corneal thickness

    Proportion of Change in thickness of cornea measured in microns

    Time frame: 1 week after refractive procedure

  7. anterior chamber depth

    Proportion of Change in depth of anterior chamber of the eye measured in microns

    Time frame: 1 day after refractive procedure

  8. anterior chamber depth

    Proportion of Change in depth of anterior chamber of the eye measured in microns

    Time frame: 1 week after refractive procedure

  9. keratometry

    Proportion of Change in corneal curvature measured in diopters

    Time frame: 1 day after refractive procedure

  10. keratometry

    Proportion of Change in corneal curvature measured in diopters

    Time frame: 1 week after refractive procedure

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Study locations

1 of 1 sites recruiting
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References and documents

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 33028265 ↗
  • Shpak 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 30499539 ↗
  • Ozsaygili 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 34231433 ↗
  • Yalcinkaya 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05856786
Responsible party
Sponsor
First posted
May 12, 2023
Start date
Jun 1, 2024
Primary completion
Mar 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Pukhraj P Rishi, MBBS
Contact
pukhraj.rishi@unmc.edu
402-559-2020
Lisa Reid
Contact
lisa.reid@unmc.edu
4025591851
Pukhraj P Rishi, MBBS
principal investigator · University of Nebraska

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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