Recruiting

Refractive Surgery

Sponsor:

University of Nebraska

Code:

NCT05856786

Conditions

Optical Coherence Tomography

Refractive Errors

Myopia

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Optical coherence tomography

Study Details

Brief 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.

Conditions

Optical Coherence Tomography

Refractive Errors

Myopia

Study ID

NCT05856786

Start date

Jun 1, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

33 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Optical 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.

Primary outcome measure

  • Macular thickness [ Time Frame: 1 day after refractive procedure ]
  • Macular thickness [ Time Frame: 1 week after refractive procedure ]

Central Contacts and Locations

Central contacts

Pukhraj P Rishi, MBBS

402-559-2020pukhraj.rishi@unmc.edu

Lisa Reid

4025591851lisa.reid@unmc.edu

Locations

Unversity of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Pukhraj P Rishi, MBBS

402-559-2020pukhraj.rishi@unmc.edu

Lisa Reid

402-559-1851lisa.reid@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-08-26.