Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (CZV_PAL1)
17 de abril de 2017 atualizado por: Meng C. Lin, University of California, Berkeley
The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each.
All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned.
At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance.
Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.
Tipo de estudo
Intervencional
Inscrição (Real)
95
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Berkeley, California, Estados Unidos, 94720-2020
- Clinical Research Center, School of Optometry, University of California, Berkeley
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
39 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Presbyope
- Experienced PAL spectacle wearer
- Correctable to at least 20/25 in both eyes
- Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction
- Able and willing to complete all laboratory measurements and questionnaire batteries
Exclusion Criteria:
- Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center
- Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study
- Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Randomized Order of Interventions 1
Randomized to first wear standard, non-free-form, non-customized PAL spectacles, then second, crossover to wear individually customized free-form surfaced PAL spectacles
|
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Outros nomes:
|
|
Comparador Ativo: Randomized Order of Interventions 2
Randomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles
|
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Acuity, High Contrast, Distance Chart
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
Visual Acuity, Low Contrast, Distance Chart
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
Visual Acuity, High Contrast, Near Chart
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
Visual Acuity, Low Contrast, Near Chart
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
30-degree Off-axis Distance Visual Acuity, High Contrast Chart
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
Horizontal Extent of Undistorted Vision at Reading Distance
Prazo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
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Questionnaire Battery
Prazo: At study exit, after both Test and Control spectacles had been worn for 1 week each
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Forced-choice Likert scale preference questionnaire
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At study exit, after both Test and Control spectacles had been worn for 1 week each
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meng C. Lin, OD, PhD, Clinical Research Center, School of Optometry, University of California, Berkeley
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2009
Conclusão Primária (Real)
1 de outubro de 2009
Conclusão do estudo (Real)
1 de outubro de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
3 de novembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de novembro de 2010
Primeira postagem (Estimativa)
4 de novembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CZV_PAL1
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