NCT04393740

Brief Summary

The magnitude of posterior corneal astigmatism was considered negligible due to the smaller difference in the refractive index between the cornea and the aqueous . though ,neglecting the posterior corneal astigmatism lead to errors during calculation of the toric iols (over or under estimation ) . so we aim to determine the percentage of contribution of posterior corneal astigmatism to total corneal astigmatism in a sample of Egyptian population using scheimpflug imaging (Pentacam ).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 14, 2020

Last Update Submit

May 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • contribution of posterior corneal astigmatism to magnitude of total corneal astigmatism

    to detect the contribution of posterior corneal astigmatism to total corneal astigmatism to avoid errors during calculation of toric Intra ocular lenses

    3 months

Interventions

corneal tomography imaging using pentacam device (based on Scheimpflug principle )

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

candidates presenting for refractive surgery .

You may qualify if:

  • Patients with corneal astigmatism(±0.5D up tp ±4 D )
  • Age (18-45 years )
  • Refractive error (myopia up to -8D)
  • Hyperopia up to +4
  • Patients who have clear cornea .
  • Good quality Scheimpflug analyzer scans.

You may not qualify if:

  • Patients who have any corneal opacity .
  • Patients who underwent any Previous corneal surgery .
  • Patients who have Co existing corneal pathology.
  • Glaucomatus patients.
  • Patients with any Concomitant ocular disease .
  • Patients with History of previous ocular trauma .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr El Aini medical school

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Ferreira TB, Ribeiro P, Ribeiro FJ, O'Neill JG. Comparison of Methodologies Using Estimated or Measured Values of Total Corneal Astigmatism for Toric Intraocular Lens Power Calculation. J Refract Surg. 2017 Dec 1;33(12):794-800. doi: 10.3928/1081597X-20171004-03.

    PMID: 29227506BACKGROUND
  • Rydstrom E, Westin O, Koskela T, Behndig A. Posterior corneal astigmatism in refractive lens exchange surgery. Acta Ophthalmol. 2016 May;94(3):295-300. doi: 10.1111/aos.12965. Epub 2016 Jan 30.

    PMID: 26825986BACKGROUND

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

alaa mo badawy, Msc

CONTACT

sarah A azzam, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of ophthalmology kasr el AINI

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

April 15, 2020

Primary Completion

July 15, 2020

Study Completion

August 15, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

we would share our protocol and results through publishing our research

Shared Documents
STUDY PROTOCOL
Time Frame
the data would be available within 3 months and would be available for 6 months

Locations