ISNT Rule in Normal Population

NCT05575154 | Unknown

• 1 other identifier: ISNT rule
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study sought to determine the percentage of normal eyes that followed the ISNT rule by retinal nerve fiber layer (RNFL) and neuroretinal rim thickness measurements using optical coherence tomography (OCT) , and secondarily, whether alternative rules may be more applicable or easily generalized.

Conditions

Glaucoma

Keywords

ISNT rule in normal population

Outcome Measures

Primary Outcomes (1)

• ISNT rule prevalence in normal population

  the percentage of normal eyes that followed the ISNT rule by retinal nerve fiber layer and neuroretinal rim thickness measurements using (OCT)

  Baseline

Secondary Outcomes (1)

• variants of ISNT rule

  Baseline

Interventions

optical coherence tomography (OCT) DEVICE

measuring retinal nerve fiber layer and neuroretinal rim thickness

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal population

You may qualify if:

• a normal eye examination without ocular diseases except for cataracts
• best corrected vision of \> 6/12
• a normal VF test result defined by a pattern standard deviation value of \> 5% compared to age matched controls in the perimeter's normative database and a glaucoma hemifield test within normal limits
• a spherical equivalent of between -5 and +5 diopters.

You may not qualify if:

• unreliable VF testing with \> 33% fixation losses, \> 20% false positives, or \> 20% false negatives.
• any history of ocular hypertension or intraocular pressures \> 21mmHg at the time of the visit;
• inter-eye cup-to-disc ratio (CDR) asymmetry of \> 0.2;CDR of \> 0.4
• history of a neurologic disease or systemic medication that could produce VF defects.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (18)

• Foster PJ, Buhrmann R, Quigley HA, Johnson GJ. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol. 2002 Feb;86(2):238-42. doi: 10.1136/bjo.86.2.238.

  PMID: 11815354 BACKGROUND

• Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.

  PMID: 21453963 BACKGROUND

• Bourne RR, Taylor HR, Flaxman SR, Keeffe J, Leasher J, Naidoo K, Pesudovs K, White RA, Wong TY, Resnikoff S, Jonas JB; Vision Loss Expert Group of the Global Burden of Disease Study. Number of People Blind or Visually Impaired by Glaucoma Worldwide and in World Regions 1990 - 2010: A Meta-Analysis. PLoS One. 2016 Oct 20;11(10):e0162229. doi: 10.1371/journal.pone.0162229. eCollection 2016.

  PMID: 27764086 BACKGROUND

• Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

  PMID: 24974815 BACKGROUND

• Keltner JL, Johnson CA, Anderson DR, Levine RA, Fan J, Cello KE, Quigley HA, Budenz DL, Parrish RK, Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. The association between glaucomatous visual fields and optic nerve head features in the Ocular Hypertension Treatment Study. Ophthalmology. 2006 Sep;113(9):1603-12. doi: 10.1016/j.ophtha.2006.05.061.

  PMID: 16949445 BACKGROUND

• Broadway DC, Nicolela MT, Drance SM. Optic disk appearances in primary open-angle glaucoma. Surv Ophthalmol. 1999 Jun;43 Suppl 1:S223-43. doi: 10.1016/s0039-6257(99)00007-7.

  PMID: 10416767 BACKGROUND

• Jonas JB, Budde WM. Diagnosis and pathogenesis of glaucomatous optic neuropathy: morphological aspects. Prog Retin Eye Res. 2000 Jan;19(1):1-40. doi: 10.1016/s1350-9462(99)00002-6.

  PMID: 10614679 BACKGROUND

• Jonas JB, Gusek GC, Naumann GO. Optic disc, cup and neuroretinal rim size, configuration and correlations in normal eyes. Invest Ophthalmol Vis Sci. 1988 Jul;29(7):1151-8.

  PMID: 3417404 BACKGROUND

• Jonas JB, Budde WM, Panda-Jonas S. Ophthalmoscopic evaluation of the optic nerve head. Surv Ophthalmol. 1999 Jan-Feb;43(4):293-320. doi: 10.1016/s0039-6257(98)00049-6.

  PMID: 10025513 BACKGROUND

• Varma R, Skaf M, Barron E. Retinal nerve fiber layer thickness in normal human eyes. Ophthalmology. 1996 Dec;103(12):2114-9. doi: 10.1016/s0161-6420(96)30381-3.

  PMID: 9003346 BACKGROUND

• Dichtl A, Jonas JB, Naumann GO. Retinal nerve fiber layer thickness in human eyes. Graefes Arch Clin Exp Ophthalmol. 1999 Jun;237(6):474-9. doi: 10.1007/s004170050264.

  PMID: 10379607 BACKGROUND

• Jonas JB, Budde WM, Lang P. Neuroretinal rim width ratios in morphological glaucoma diagnosis. Br J Ophthalmol. 1998 Dec;82(12):1366-71. doi: 10.1136/bjo.82.12.1366.

  PMID: 9930265 BACKGROUND

• Harizman N, Oliveira C, Chiang A, Tello C, Marmor M, Ritch R, Liebmann JM. The ISNT rule and differentiation of normal from glaucomatous eyes. Arch Ophthalmol. 2006 Nov;124(11):1579-83. doi: 10.1001/archopht.124.11.1579.

  PMID: 17102005 BACKGROUND

• Law SK, Kornmann HL, Nilforushan N, Moghimi S, Caprioli J. Evaluation of the "IS" Rule to Differentiate Glaucomatous Eyes From Normal. J Glaucoma. 2016 Jan;25(1):27-32. doi: 10.1097/IJG.0000000000000072.

  PMID: 24844540 BACKGROUND

• Morgan JE, Bourtsoukli I, Rajkumar KN, Ansari E, Cunliffe IA, North RV, Wild JM. The accuracy of the inferior>superior>nasal>temporal neuroretinal rim area rule for diagnosing glaucomatous optic disc damage. Ophthalmology. 2012 Apr;119(4):723-30. doi: 10.1016/j.ophtha.2011.10.004. Epub 2012 Feb 24.

  PMID: 22365059 BACKGROUND

• Dave P, Shah J. Applicability of ISNT and IST rules to the retinal nerve fibre layer using spectral domain optical coherence tomography in early glaucoma. Br J Ophthalmol. 2015 Dec;99(12):1713-7. doi: 10.1136/bjophthalmol-2014-306331. Epub 2015 May 28.

  PMID: 26021327 BACKGROUND

• Pradhan ZS, Braganza A, Abraham LM. Does the ISNT Rule Apply to the Retinal Nerve Fiber Layer? J Glaucoma. 2016 Jan;25(1):e1-4. doi: 10.1097/IJG.0000000000000064.

  PMID: 24777047 BACKGROUND

• Sihota R, Srinivasan G, Dada T, Gupta V, Ghate D, Sharma A. Is the ISNT rule violated in early primary open-angle glaucoma--a scanning laser tomography study. Eye (Lond). 2008 Jun;22(6):819-24. doi: 10.1038/sj.eye.6702798. Epub 2007 Apr 13.

  PMID: 17435693 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Abd-Elnasser A Mohamed, PhD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Amr M Sayed, M.B.B.Ch.

CONTACT

+201096083988; amr_mohamed_sayed3@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident ophthalmologist

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 12, 2022
• Study Start: December 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10