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Assessment of IOP After Corneal Refractive Surgery Based on AI

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Summary

NCT07544615 is an observational study registered on ClinicalTrials.gov assessing intraocular pressure (IOP) changes after corneal refractive surgery using artificial intelligence. The study, registered by NIH on April 22, 2026, examines conditions including myopia, astigmatism, and refractive surgery outcomes. Clinical investigators will monitor approximately 100 participants to evaluate how corneal biomechanical changes affect IOP readings with various tonometers.

“Postoperative intraocular pressure (IOP) monitoring is a crucial observation index.”

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About this source

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What changed

NCT07544615 is a newly registered observational clinical trial examining intraocular pressure outcomes following corneal refractive surgery. The study focuses on myopia, astigmatism, and refractive surgery conditions, using AI to assess how corneal thinning and biomechanical changes affect IOP readings with different tonometers.

For eye care professionals and clinical researchers, this registration represents an upcoming evidence source on post-surgical ocular health monitoring. Healthcare providers performing corneal refractive procedures may benefit from tracking this study's findings on accurate IOP measurement techniques in post-LASIK and SMILE patients.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Assessment of IOP After Corneal Refractive Surgery Based on AI

Observational NCT07544615 Kind: OBSERVATIONAL Apr 22, 2026

Abstract

Significance, Background, and Current Status Studies show the global average prevalence of myopia is 22%, with hyperopia incidence being similar. In China, the myopia prevalence is 31%, making it one of the countries with the highest rates of myopia. Currently, the safety and efficacy of corneal refractive surgery (CRS), such as LASIK and SMILE, for correcting myopia, hyperopia, and other refractive errors are well-established. An increasing number of patients undergo CRS to alleviate the inconveniences caused by refractive errors. While LASIK has long been regarded as a classic procedure, since the first report of Small Incision Lenticule Extraction (SMILE) for myopia correction in 2008, it has evolved into one of the mainstream surgical techniques. With the rapid advancement of refractive surgery, minimizing postoperative complications while maintaining excellent visual outcomes has become a major focus for clinicians. Postoperative intraocular pressure (IOP) monitoring is a crucial observation index.

Theoretically, IOP should not change significantly after CRS, as the surgery does not affect aqueous humor dynamics or intraocular volume. However, numerous studies indicate that alterations in corneal shape and biomechanical properties, particularly corneal thinning, lead to artificially low IOP readings with various tonometers, especially those dependent on corneal thickness. Furthermore, postoperative management often requires prolonged use of corticosteroid eye drops t...

Conditions: Myopia, Myopia; Astigmatism, Refractive Surgery, Intraocular Pressure Changes

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07544615

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial research Ophthalmic monitoring Medical device assessment
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Healthcare Medical Devices

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