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Status unknownNCT05486741Updated Aug 4, 2022

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

An observational study in OCT Study RNFL and Macular Thickness, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
450
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the 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

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Conditions studied

  • OCT Study RNFL and Macular Thickness

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Keywords

  • OCT study
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In context

Hyperopia

140 studies on the registry are indexed under Hyperopia; 18 are open to participants now.

This study's planned enrollment of 450 is above the median of 174 across 24 observational studies indexed under Hyperopia.

Browse Hyperopia studies →

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.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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).

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

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
450 participants (estimated)
Patient registry
No

Groups and cohorts

  • Myopes

    myopes (≤ -1.0 D)

    Other: Optical cehernce tomography

  • Hyperopes

    hyperopia (≥ +1.0D).

    Other: Optical cehernce tomography

  • Emmetropes

    emmetropes (\> -1.0 to \< * 1.0 D)

    Other: Optical cehernce tomography

Interventions

  • OtherOptical cehernce tomography

    OCT macula and disc

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What researchers measure

Primary outcomes

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

    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

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hussein M, Ibrahim S, Taha A, Magdy R. The impact of error of refraction and retinal nerve fiber layer thickness on cognitive functions in adults with bilateral myopia. Int J Neurosci. 2023 Mar;133(3):290-295. doi: 10.1080/00207454.2021.1910260. Epub 2021 May 17. PubMed 33781167 ↗
  • Leung CK, Mohamed S, Leung KS, Cheung CY, Chan SL, Cheng DK, Lee AK, Leung GY, Rao SK, Lam DS. Retinal nerve fiber layer measurements in myopia: An optical coherence tomography study. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5171-6. doi: 10.1167/iovs.06-0545. PubMed 17122099 ↗
  • Wang Q, Klein BE, Klein R, Moss SE. Refractive status in the Beaver Dam Eye Study. Invest Ophthalmol Vis Sci. 1994 Dec;35(13):4344-7. PubMed 8002254 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05486741
Lead sponsor
Assiut University
Responsible party
Mirna Tawab Saied (Doctor, Assiut University) — Principal investigator
First posted
Aug 4, 2022
Start date
Nov 2022 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 4, 2022

Study contacts

Mirna Tawab Saied
Contact
mirnatawab56@gamil.com
01221353527
Magdy Mohamed mostafa
Contact

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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