Retinal Nerve Fiber Layer Thickness and Macular Thickness in Myopia, Hyperopia and Emmetropia : An OCT Study

August 2, 2022 updated by: Mirna Tawab Saied, Assiut University

Retinal Nerve Fiber Layer Thickness and Macular Thinckness in Myopia, Hyperopia and Emmetropia : An OCT Study

The purpose of this study is to investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The world health organization (WHO) has estimated that the visual impairment caused by uncorrected refractive errors to be present in 153 million people worldwide (1) the prevalence of myopia ranges from 22.7% to 38.7% in large population study According to the WHO regions the estimated prevalence (EP) of hyperopia is 30.6% with the lowest EP in south east Asia 2.2% and the highest EP in the Americas 14.3% (2-3) During optic nerve development 2.85 million nerve fibers exist but by the third trimester we lose about 35% of these fibers (4) and the perpapillary retinal nerve fiber layer (RNFL) thickness will continue to decrease with advancing age (5). The relationship of the RNFL thickness with the refractive errors has been extensively investigated in adults and in children (6) and there was significant increase in the RNFL thickness in hypermetrope than in emmetrope and myope Understanding the derminants that affect the RNFL reserve helps us in the diagnosis and monitoring of optic nerve diseases. In macular region the thickness measured through optocal coherent tomography OCT shows high variability with value ranging from 190mm (centerpoint) to 389 mm (superior inner/nasal inner macula) (7) for both retinal and macular regions while decreasing in the retinal thickness has been reported with increasing age. Different studies have shown racial differences in RNFL thickness (8) white race (9) and myopia which has high prevelance in East Asian regions (10-12) have been associated with thinner RNFL (11) on the contrary Asian or Hispanic race has been associated with a thicker RNFL

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Magdy Mohamed mostafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with errors of refraction devided into 3 groups myopes (≤ -1.0 D) ; emmetropes (> -1.0 to <

  • 1.0 D) and hypermetropia (≥ +1.0D).

Description

Inclusion Criteria:

  • All individuals having similar type of refractive status in both eyes and with no known confounding factor affecting retinal intensity or CDVA and willing to participate.

Exclusion Criteria:

  • • Eyes with amplyopia

    • Patients having posterior segment pathology or media opacity
    • Patients with history of glaucoma
    • History of retinal laser therapy
    • History of ocualr trauma
    • Any medical disease that prevents patients from positioning on the device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Myopes
myopes (≤ -1.0 D)
Other: Optical cehernce tomography
OCT macula and disc
Hyperopes
hyperopia (≥ +1.0D).
Other: Optical cehernce tomography
OCT macula and disc
Emmetropes

emmetropes (> -1.0 to <

  • 1.0 D)
Other: Optical cehernce tomography
OCT macula and disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal nerve fiber layer thickness and macular thickness in myopia , hyperopia and emmetropia : An OCT study
Time Frame: Baseline
investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia The peripapillary RNFL thickness in central ,perimacular and paramacular regions will be measured using the OCT and compared between three groups of refractive states
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

November 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (ACTUAL)

August 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCT study in refractive errors

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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