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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05486741
Collaborator
(none)
450
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Optical cehernce tomography

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 Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Retinal Nerve Fiber Layer Thickness and Macular Thinckness in Myopia, Hyperopia and Emmetropia : An OCT Study
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Retinal nerve fiber layer thickness and macular thickness in myopia , hyperopia and emmetropia : An OCT study [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mirna Tawab Saied, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05486741
Other Study ID Numbers:
  • OCT study in refractive errors
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mirna Tawab Saied, Doctor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022