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NCT Number: NCT06278220

Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations

Aim of work:

To assess the agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) regard measuring corneal higher order aberrations before and after LASIK.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Naglaa Moustafa

Asyut, Egypt

About this study

Higher-order aberrations (HOAs) are small optical irregularities of the eye, which can have an impact on the quality of the retinal image. In contrast to lower order aberrations, these errors cannot be corrected with regular spectacles and most contact lenses. Additionally, HOAs are responsible for an array of visual symptoms including dysphotopsia, glare, as well as a reduction in contrast sensitivity. The cornea accounts for approximately 90% of ocular aberrations.Advances and breakthroughs in wavefront aberration measurement technology can help clinicians to better understand and manage corneal higher-order aberrations (HOAs), especially for the preoperative planning of corneal refractive surgery and cataract surgery.A recent study has shown that corneal HOAs can be a sensitive parameter to differentiate early keratoconus from normal eyes. Furthermore, corneal aberrations have been widely used to evaluate dry eye and orthokeratology.LASIK surgery is widely used in the correction of refractive errors It is well known that LASIK surgery induces high-order aberrations (HOA) .The main eye element involved in the generation of such aberrations is the first corneal surface. Currently, devices based on Placido-disc, Hartmann- Shack, ray tracing, or Scheimpflug are routinely used in clinical aberration measurement. Of which Pentacam is one of common instruments that can only measure corneal aberration (including anterior and posterior corneal surface) based on Scheimpflug technology. Also Allegro Topolyzer is a Placido-based topographer that can measure anterior corneal higher order aberrations (HOAs). A better understanding of the agreement of device measurements can provide clinicians with useful information for measuring, correcting, and monitoring aberrations around refractive and cataract surgery. Investigators , therefore, aimed to study the agreement between the two instruments in anterior corneal aberration measurement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with refractive errors from +6 diopters to -8 diopters sphere and up to -6diopters cylinder.

Exclusion criteria

  • Patients with systemic diseases such as diabetes.
  • keratoconus or keratoconus suspect, amblyopic eyes.
  • Patients with best corrected visual acuity (BCVA) not achieving 20/25.
  • glucoma
  • Previous ocular surgeries or trauma.

Treatment and study plan

placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam )

Device

An informed written consent will be obtained from all patients that will be included in this study. Patients in this study will undergo pentacam and topolyzer examination to asses corneal high order aberrations before LASIK procedure.

Patients will be assigned to undergo LASIK. Follow up pentacam and topolyzer examination will be done 3 months after LASIK.

Primary outcomes

  1. Agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (pentacam)

    Time frame: Before LASIK and 3 months after LASIK

    Agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (pentacam) regard measuring corneal high order aberrations before and after LASIK.

Secondary outcomes

  1. Changes in high order aberrations after LASIK.

    Time frame: Before LASIK and 3 months after LASIK

    Changes in high order aberrations after LASIK using pentacam and topolyzer

Study contacts

Contact information is provided by the study sponsor or research team.

Naglaa MA Abdelmohsen, MD

CONTACT

[email protected]

+201095459579

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations Before and After LASIK

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 26, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.