NCT04913883

Brief Summary

To determine the effectiveness of correcting astigmatism by laser refractive surgery by a vectorial astigmatism outcome analysis that uses 3 fundamental vectors : target induced astigmatism vector ( TIA) , surgically induced astigmatism vector , and difference vector , as described by Alpins method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

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

First Submitted

Initial submission to the registry

May 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 4, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 25, 2021

Last Update Submit

May 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • . Post operative Visual Acuity

    To determine the effectiveness of correcting astigmatism by laser refractive surgery by a vectorial astigmatism outcome analysis by : CDVA and UCDVA, pentacam , 3 month, 6 month and 1 year after surgery. * 3 months postoperative : assessment of visual acuity using corrected distance visual acuity (CDVA) , and uncorrected distance visual acuity (UCDVA) and pentacam measures . * 6 months postoperative : assessment of visual acuity using corrected distance visual acuity (CDVA) , and uncorrected distance visual acuity (UCDVA) and pentacam measures . * One year postoperative : assessment of visual acuity using corrected distance visual acuity (CDVA) , and uncorrected distance visual acuity (UCDVA) and pentacam measures .

    one year

Secondary Outcomes (1)

  • Postoperative Assessment

    3 months

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study will include 50 patients in different ages .

You may qualify if:

  • At least 18 years of age .
  • Stable eyeglass and contact lenses prescription for at least 2 to 3 years .
  • Stable vision over at least the past year .
  • No history or findings of active corneal disease .
  • No significant dry eye .
  • Not pregnancy or nursing .
  • Refractive cylinder more than -1D (Diopter) .

You may not qualify if:

  • Certain conditions make the method inadvisable :
  • Residual , recurrent or active ocular disease such as uveitis , sever dry eyes , sever allergic eye disease , glaucoma visually significant cataract , and retinal disease .
  • Previous corneal surgery or trauma within the corneal flap zone .
  • Patent corneal vascularisation within 1mm of the corneal flap zone .
  • Age less than 18 years old .
  • Pregnancy or breast feeding .
  • Certain medical conditions such as autoimmune diseases (eg. lupus , rheumatoid arthritis), immunodeficiency states (eg. HIV) and diabetes may prevent proper healing after a refractive procedure.
  • Systemic medications likely to affect wound healing such as retinoic acid and steroids .
  • Keratoconus or other active eye disease .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alpins N. Astigmatism analysis by the Alpins method. J Cataract Refract Surg. 2001 Jan;27(1):31-49. doi: 10.1016/s0886-3350(00)00798-7.

    PMID: 11165856BACKGROUND

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Abdelnasser Awad, Professor

    Ophthalmology Department

    PRINCIPAL INVESTIGATOR
  • Khaled Abdelazeem, Asst. Prof

    Ophthalmology Department

    PRINCIPAL INVESTIGATOR
  • Mohamed Anwer, Lecturer

    Ophthalmology Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esraa Fathy, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Ophthalmologist at Assiut Police Hospital

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 4, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

June 4, 2021

Record last verified: 2021-05