Patient-reported outcome measures in presbyopia: a literature review

Sharma, Gyanendra; Chiva-Razavi, Sima; Viriato, Daniel; Naujoks, C; Patalano, Francesco; Bentley, Sarah; Findley, Amy; Johnson, Chloe; Arbuckle, Rob; Wolffsohn, James S.

doi:10.1136/bmjophth-2020-000453

Cited by 21 publications

(28 citation statements)

References 40 publications

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“…Previous studies of presbyopia treatment using various treatment modalities [3] used arbitrary numerical criteria to determine treatment efficacy because of the absence of standardized criteria. The patient-reported outcome measures have also been used in clinical trials and quality-of-life studies for presbyopia treatment [3,4]. Among them, the Near Activity Visual Questionnaire was identified as the most appropriate for assessing near-vision functioning in presbyopia, although the measure was not validated in a purely phakic presbyopia sample [4].…”

Section: Introductionmentioning

confidence: 99%

“…The patient-reported outcome measures have also been used in clinical trials and quality-of-life studies for presbyopia treatment [3,4]. Among them, the Near Activity Visual Questionnaire was identified as the most appropriate for assessing near-vision functioning in presbyopia, although the measure was not validated in a purely phakic presbyopia sample [4]. Considering recent developments of presbyopia treatments using various modalities [3,[5][6][7][8][9], simple and easily accessible standardized criteria for diagnosis and endpoints of treatment are necessary.…”

Section: Introductionmentioning

confidence: 99%

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Determination of the Standard Visual Criterion for Diagnosing and Treating Presbyopia According to Subjective Patient Symptoms

Tsuneyoshi

Masui

Arai

et al. 2021

JCM

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Presbyopia treatments using various modalities have been developed recently; however, no standard criteria exist for the diagnosis and treatment endpoint. This study assessed the relationship between the near visual acuity (NVA) and the subjective symptoms of phakic presbyopia and determined the numerical NVA threshold to diagnose phakic presbyopia and evaluate the effectiveness of presbyopia treatment. The binocular distance, NVA with habitual correction, and monocular conventional VA were measured. Patients were asked about their awareness of presbyopia and difficulty performing near tasks. This prospective observational study included 70 patients (mean age, 56.0 years; range, 32–77). Most patients became aware of presbyopia in their late forties, although some had difficulty with vision-related near tasks before becoming aware of presbyopia. Eighty three percent of patients (20/24) experienced difficulty with near vision-related tasks even with excellent NVA at 40 cm with habitual correction of 0.0 logMAR (20/20 in Snellen VA). In conclusion, the current study showed that patients became aware of presbyopia in their late forties, although some had difficulty with near vision-related tasks before becoming aware of presbyopia. Further investigation should include the proposal of appropriate diagnostic criteria for presbyopia and better management for patients with presbyopia.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Determination of the Standard Visual Criterion for Diagnosing and Treating Presbyopia According to Subjective Patient Symptoms

Tsuneyoshi

Masui

Arai

et al. 2021

JCM

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“…Existing clinical assessment tools (such as visual acuity assessment through use of a standardised Snellen chart) lack adequate assessment of the individual experience of presbyopia, highlighting the need for patient-reported outcome (PRO) instruments in this specific population. A recent literature review found there was a paucity of PROs developed for use in phakic presbyopia in line with the Food and Drug Administration (FDA) PRO guidance [ 16 ]. Phakic presbyopia is presbyopia that occurs for an individual who still has a natural lens, as opposed to pseudophakic presbyopia where the individual no longer has a natural lens (such as following surgery).…”

Section: Introductionmentioning

confidence: 99%

“…{Paley [ 17 ]} Instruments such as the Near Activity Visual Questionnaire (NAVQ) [ 18 ], National Eye Institute Visual Function Questionnaire (NEI VFQ-25) [ 19 ], National Eye Institute Refractive Error Quality of Life Instrument-42 (NEI RQL-42) [ 20 ] were among those identified as PRO instruments that assess vision outcomes of presbyopia or similar conditions. The FDA guidance outlines the requirement of evidence of content validity in a given context of use for existing, modified, or newly created PRO instruments used to support claims in approved medical product labelling [ 16 , 21 ]. The NAVQ was the only PRO identified by the literature review as a suitable instrument to assess patient-reported near vision function [ 16 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the content validity of patient-reported outcome (PRO) instruments developed for use with individuals with phakic presbyopia, including the Near Activity Visual Questionnaire-presbyopia (NAVQ-P) and the near vision correction independence (NVCI) instrument

Bentley

Findley

Chiva-Razavi

et al. 2021

J Patient Rep Outcomes

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Background Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia. Methods Participants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a “think-aloud” process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds. Results The participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity. Conclusions Developed in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments.

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“…Presbyopia is a physiologic inevitability and aging is the primary etiology. With the development of society, the overuse of portable computers and smartphones has become an important cause of presbyopia [3,4]. Geographic and sex factors have also been reported [5,6].…”

Section: Introductionmentioning

confidence: 99%

Improvement of Presbyopia Using a Mixture of Traditional Chinese Herbal Medicines, Including Cassiae Semen, Wolfberry, and Dendrobium huoshanense

Horng

Ma²,

Shieh

2021

Evidence-Based Complementary and Alternative Medicine

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Background. Presbyopia is a primary cause of a decline in near vision. In this study, we developed a new mixed herbal medicine to retard presbyopic progression and increase the amplitude of accommodation (AA), which is beneficial for near vision. Methods. A total of 400 participants between the ages of 45 and 70 years were recruited. We designed the mixed herbal drug to include Cassiae Semen (200 mg), wolfberry (200 mg), and Dendrobium huoshanense (DD) (40 mg) in one capsule. In experiment 1, the recruited subjects were directed to perform a push-up test to measure their AA; this was then converted to the additional diopters of reading glasses. In experiment 2, 240 subjects took three capsules daily for six months and then stopped medical therapy for a six-month follow-up. In experiment 3, 160 subjects were randomly categorized into four groups: a placebo group, low-dose group (LDG) (1 capsule daily), middle-dose group (MDG) (two capsules daily), and high-dose group (HDG) (three capsules daily). The 160 volunteers took different doses for six months and then stopped treatment, accompanied by another six-month follow-up. In experiments 2 and 3, the change in AA, uncorrected far visual acuity (UFVA), and uncorrected near visual acuity (UNVA) were recorded each month for one year. Results. In experiment 1, AA was found to decrease with age and a great deal of additional power was needed in older individuals. In experiment 2, the mean AA reached a maximum value of 2.1D ( P < 0.05) after six months, while the UNVA improved by about two to three lines of a Jaeger chart in most of the subjects. At nine months, all the means decreased slightly to 2.0 D ( P < 0.05). This meant that the mixed herbal medicine could still maintain AA for another three months because the herbal therapy was stopped at the seventh month. In experiment 3, the maximal AA was 2.8D, 2.9D, and 3.2D ( P < 0.05) in the LDG, MDG, and HDG after six-month treatments, respectively. Experiment 3 showed that AA gain occurred in a dose-dependent manner; the higher the dose, the greater the AA value. Conclusion. Only two studies on the use of herbal drugs for presbyopia have been reported in PubMed. In our study, we found that taking a mixed herbal drug caused an excellent gain in AA. This is the first study to report that the characteristics of the new herbal regimen could retard and even ameliorate presbyopia.

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Patient-reported outcome measures in presbyopia: a literature review

Cited by 21 publications

References 40 publications

Determination of the Standard Visual Criterion for Diagnosing and Treating Presbyopia According to Subjective Patient Symptoms

Determination of the Standard Visual Criterion for Diagnosing and Treating Presbyopia According to Subjective Patient Symptoms

Evaluation of the content validity of patient-reported outcome (PRO) instruments developed for use with individuals with phakic presbyopia, including the Near Activity Visual Questionnaire-presbyopia (NAVQ-P) and the near vision correction independence (NVCI) instrument

Improvement of Presbyopia Using a Mixture of Traditional Chinese Herbal Medicines, Including Cassiae Semen, Wolfberry, and Dendrobium huoshanense

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