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ISNT Rule in Normal Population

Is the ISNT Rule Still a Rule : a Study to Determine Prevalence of the ISNT Rule and Its Variants in the Normal Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05575154
Enrollment
116
Registered
2022-10-12
Start date
2022-12-01
Completion date
2023-12-30
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

ISNT rule in normal population

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.

Detailed description

Glaucoma is a disease of the optic nerve, which results in structural optic nerve head (ONH) damage and functional visual field (VF) loss. It has increased as a cause of global blindness from 4.4% in 1990 to 6.3% in 2010. Its global prevalence is also increasing from 3.54% or 64.3 million people in 2013 to a projected 111.8 million people by 2040. Detection of structural ONH damage is critical for early diagnosis, because ONH changes usually precede VF loss. Two cornerstone elements of the ONH and peripapillary examination are stereo disc photography and optical coherence tomography (OCT) retinal nerve fiber layer (RNFL) thickness measurements. By analyzing the neuroretinal rim in disc photos of normal subjects, Jonas et al found that the rim width typically exhibited a specific pattern of the inferior (I) rim being the widest, followed by the superior (S) rim, then the nasal (N) rim, and then the temporal (T) rim being the thinnest. This specific neuroretinal rim pattern was later coined by Elliot Werner as the ISNT rule. Because neuroretinal rim loss is a hallmark feature of glaucoma, patients who deviate from the ISNT rule may need to be watched more closely for glaucoma. The RNFL, on the other hand, has also been shown in histological studies in normal, non-glaucomatous eyes to exhibit a similar pattern of the inferior quadrant being the thickest, followed by the superior, nasal, then temporal quadrant. Since RNFL thinning, particularly in the superior and inferior quadrants, is also a characteristic structural change in glaucoma, deviation from the ISNT rule for RNFL thickness may also be an early indicator of glaucomatous structural change. Therefore, many investigators have sought to determine whether the ISNT rule, either applied to the neuroretinal rim disc photos or to RNFL thickness measurements, is useful in the diagnosis of glaucoma or not. However, the optic disc photo ISNT rule studies are conflicting, with some finding the ISNT rule and its variants clinically useful, while others have not. In contrast, RNFL ISNT rule studies based on OCT findings are in uniform agreement, stating that the ISNT rule and its variants were not helpful in the diagnosis of glaucoma. Some have hypothesized that the ISNT rule is not easily generalizable to the individual, because the initial studies were derived from mean values. Therefore, some of the limitations of the ISNT rule may stem from the fact that it is unclear what percentage of individual normal eyes follow the ISNT rule. Other limitations may arise from the fact that perhaps other rules may be more common in the normal population.

Interventions

DEVICEoptical coherence tomography (OCT)

measuring retinal nerve fiber layer and neuroretinal rim thickness

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
variants of ISNT ruleBaselinewhether alternative rules may be more applicable or easily generalized than the ISNT rule like IS,IST, TSINT rule .

Contacts

Primary ContactAmr M Sayed, M.B.B.Ch.
amr_mohamed_sayed3@yahoo.com+201096083988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026