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Not yet recruitingNCT06278220Updated Feb 28, 2024

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

An observational study in Corneal Higher-order Aberrations, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Corneal Higher-order Aberrations

Keywords

  • higher-order aberrations
  • Pentacam
  • Topolyzer
  • LASIK
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who will undergo LASIK

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
36 participants (estimated)
Patient registry
No

Interventions

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

    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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: Before LASIK and 3 months after LASIK

Secondary outcomes

  1. Changes in high order aberrations after LASIK.

    Changes in high order aberrations after LASIK using pentacam and topolyzer

    Time frame: Before LASIK and 3 months after LASIK

07

Study locations

1 site
  • Naglaa Moustafa
    Assiut, Egypt
08

References and documents

Publications

  • Salman A, Kailani O, Ghabra M, Omran R, Darwish TR, Shaaban R, Ibrahim H, Alhaji H, Khalil H. Corneal higher order aberrations by Sirius topography and their relation to different refractive errors. BMC Ophthalmol. 2023 Mar 16;23(1):104. doi: 10.1186/s12886-023-02841-4. PubMed 36927406 ↗
  • Little JA, McCullough SJ, Breslin KM, Saunders KJ. Higher order ocular aberrations and their relation to refractive error and ocular biometry in children. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):4791-800. doi: 10.1167/iovs.13-13533. PubMed 25028356 ↗
  • Ning R, Huang X, Jin Y, Lei CS, Ma X, Xu S, Xiahou J, Savini G, Schiano-Lomoriello D, Wang X, Zhou X, Huang J. Corneal Higher-Order Aberrations Measurements: Precision of SD-OCT/Placido Topography and Comparison with a Scheimpflug/Placido Topography in Eyes After Small-Incision Lenticule Extraction. Ophthalmol Ther. 2023 Jun;12(3):1595-1610. doi: 10.1007/s40123-023-00693-1. Epub 2023 Mar 2. PubMed 36862309 ↗
  • Lou W, Du W, Jin H, Hu Y. Comparison of anterior corneal aberrations measured by Scheimpflug and Placido Disc System for myopes. BMC Ophthalmol. 2022 Dec 28;22(1):512. doi: 10.1186/s12886-022-02753-9. PubMed 36578031 ↗
  • Miret JJ, Rojas E, Camps VJ, Garcia C, Caballero MT, Martín B, et al. Understanding the Real Effect of the High-Order Aberrations after Myopic Femto-Lasik. Optics. 2022;3(4):384-99.
  • Mai EL, Chang CK, Lee CY, Lian IB, Chao CC. Higher-Order Aberrations of Topography-Guided LASIK and Wavefront-Optimized LASIK in High- and Low-Myopic Eyes: A Non-Randomized Controlled Trial. J Pers Med. 2023 Feb 24;13(3):399. doi: 10.3390/jpm13030399. PubMed 36983581 ↗
  • Piccinini AL, Golan O, Hafezi F, Randleman JB. Higher-order aberration measurements: Comparison between Scheimpflug and dual Scheimpflug-Placido technology in normal eyes. J Cataract Refract Surg. 2019 Apr;45(4):490-494. doi: 10.1016/j.jcrs.2018.11.015. Epub 2019 Jan 31. PubMed 30713018 ↗
  • Ortiz-Toquero S, Rodriguez G, de Juan V, Martin R. Repeatability of Wavefront Aberration Measurements With a Placido-Based Topographer in Normal and Keratoconic Eyes. J Refract Surg. 2016 May 1;32(5):338-44. doi: 10.3928/1081597X-20160121-04. PubMed 27163620 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06278220
Lead sponsor
Assiut University
Responsible party
Naglaa Mostafa Abdelhafez Abdelmohsen (Assistant lecturer, Assiut University) — Principal investigator
First posted
Feb 26, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Feb 28, 2024

Study contacts

Naglaa MA Abdelmohsen, MD
Contact
dr.naglaa15@gmail.com
+201095459579
Tarek A Ali, Professor
study director · Assiut University
Khaled A Mohamed, Assistant prof
study director · Assiut University
Islam M Goda, Lecturer
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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