Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing

January 2023 | Volume 22 | Issue 1 | 74 | Copyright © January 2023


Published online December 31, 2022

Brian S. Biesman MDa, Amit Verma DrPH MPHb, Nuo Cheng MSc, Ashlee W. Duncan MS PhDb

aDivisions of Ophthalmology, Dermatology, and Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN bGlobal Clinical Development, Merz North America, Raleigh, NC
cClinical Reporting, Novella Clinical, Morrisville, NC

Abstract
Background: The infraorbital hollow is characterized by a sunken hollowing appearance of the junction between the lower eyelid and the cheek. Dermal fillers provide a suitable option to reduce the appearance of infraorbital hollowing. To objectively evaluate treatmentrelated improvements in clinical practice and research, a validated photonumeric scale is needed.
Objective: To present the scale development methods for the Merz Infraorbital Hollow Assessment Scale and establish its reliability and clinical relevance.
Methods: A 5-point photonumeric scale was developed to objectively assess the infraorbital hollowing among subjects of varying sex, age, and skin type. Intra- and inter-rater reliability was evaluated using live assessments conducted 2 weeks apart. The clinical relevance of a 1-point difference in scale-severity grade was evaluated through side by-side comparisons of photographs with either same grade or a one-grade difference.
Results: The scale demonstrated excellent reliability when used by trained physicians and other healthcare practitioners. Intra-rater agreement between the 2 live-subject rating sessions was nearly perfect. Substantial inter-rater agreement between the raters from both live sessions was also demonstrated. The mean absolute difference (95% confidence interval) in scale ratings was 1.08 (1.02, 1.14) for "clinically different" pairs and was 0.34 (0.27, 0.41) for "clinically same" pairs, suggesting a 1-point difference is clinically relevant.
Conclusion: The Merz Infraorbital Hollow Assessment Scale is a validated, reliable, and clinically relevant photonumeric scale for rating infraorbital hollowing. The scale maintains its validity and reliability with reproducible results across a diverse group of males and females of various ages and Fitzpatrick Skin Types.

J Drugs Dermatol. 2023;22(1):74-81.doi:10.36849/JDD.7191

Citation: Biesman B, Verma A, Cheng N, et al. Development and validation of a photonumeric scale for evaluation of infraorbital hollowing. J Drugs Dermatol. 2023;22(1):74-81. doi: 10.36849/JDD.7191.

INTRODUCTION

The youthful-appearing individual has a relatively smooth contour in the anatomic transition from the periorbital region to the face; however, with increasing age, a noticeable concave deformity may develop in the under-eye area. This hollowing of the infraorbital region is characterized by a sunken appearance of the junction between the lower eyelid and the cheek and often results in a fatigued appearance. The infraorbital hollow (IOH) is a natural consequence of the aging face due to several anatomical and physiological factors, including the herniating lower eyelid periorbital fat, the descent of the malar fat pad, and the fixed position of periorbital ligaments. Common "dark circles" are often a result of shadowing associated with deepening of the IOH.1

Since loss of tissue volume is one contributor to the multifactorial etiology of infraorbital hollowing, patients may seek minimally invasive treatments, including dermal fillers, to restore volume and improve facial appearance. Use of such treatments should yield meaningful and measurable aesthetic improvement from baseline on scientifically valid assessment scales.

The current work introduces the development and validation of a new Merz Infraorbital Hollow Assessment Scale (MIHAS) designed to objectively rate hollowing of the infraorbital rim. Based on previously published methodology for other aesthetic assessment scales,2-7 the objectives of the current study were to establish the intra- and inter-rater reliability of the MIHAS and demonstrate a 1-point difference in scale severity grade is clinically relevant.

MATERIALS AND METHODS

Merz Infraorbital Hollow Assessment Scale Development, Layout, and Finalization
Figure 1 illustrates the process for development and validation of the MIHAS. A team comprised of board-certified physicians (eg,
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