- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02228109
Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population (BUICK)
The purpose of this study is to use a corneal topographer, a device that is readily available in most optometric practices, in order to determine the position of the multifocal (MF) contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this study is to evaluate if there is a relationship between the positioning of the optics of the study lenses and the objective and subjective visual performance as well as participant satisfaction. The MF CL lenses will be fitted to two groups of participants (previously unsuccessful vs. currently successful MF CL wearers).
HYPOTHESES
- The measurement of the power distribution acquired from the Medmont E300 corneal topographer is effective in determining MF CL lens centration and is a predictor of MF CL success.
- There is a difference in MF CL centration, determined by corneal topography, between successful and unsuccessful MF CL wearers.
- MF CL centration, determined by corneal topography, is correlated with visual performance, determined by ocular aberrometry, measures of visual acuity and subjective satisfaction.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ontario
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Waterloo, Ontario, Canadá, N2L 3G1
- Centre for Contact Lens Research, University of Waterloo
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is at least 42 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has previous experience with wearing MF CLs;
- Is able to be successfully fitted with all study lenses;
- Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive) in both eyes;
- Has a spectacle cylinder ≤0.75D in both eyes;
- Requires a reading addition of ≥+1.00D;
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment;
- Is aphakic;
- Has undergone refractive error surgery;
- Has monocular best-corrected VA of worse than 20/30 in each eye;
- Has amblyopia or strabismus;
Has anisometropia >2D between both eyes
- For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Acuvue Oasys for Presbyopia
Acuvue Oasys for Presbyopia contact lenses worn
|
Acuvue Oasys for Presbyopia contact lenses worn
|
|
Experimental: PureVision2 for Presbyopia
PureVision2 for Presbyopia contact lenses worn
|
PureVision2 for Presbyopia contact lenses worn
|
|
Experimental: Biofinity Multifocal
Biofinity Multifocal contact lenses worn
|
Biofinity Multifocal contact lenses worn
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Decentration
Prazo: Day 1
|
Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.
|
Day 1
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Acuity (high contrast) at distance
Prazo: Day 1
|
Visual Acuity (high contrast) (logMAR) at distance 6m
|
Day 1
|
|
Visual Acuity (high contrast) at intermediate distance
Prazo: Day 1
|
Visual Acuity (high contrast) (logMAR) at intermediate distance 1m
|
Day 1
|
|
Visual Acuity (high contrast) at near
Prazo: Day 1
|
Visual Acuity (high contrast) (logMAR) at near (0.4m)
|
Day 1
|
|
Visual Acuity (low contrast) at distance
Prazo: Day 1
|
Visual Acuity (low contrast) at distance 6m
|
Day 1
|
|
Visual Acuity (low contrast) at intermediate distance
Prazo: Day 1
|
Visual Acuity (low contrast) (logMAR) at intermediate distance 1m
|
Day 1
|
|
Visual Acuity (low contrast) at near
Prazo: Day 1
|
Visual Acuity (low contrast) (logMAR) at near (0.4m)
|
Day 1
|
|
Overall subjective rating of lens performance in real world tasks
Prazo: Day 1
|
Participants rate overall satisfaction with vision with the contact lenses on a scale of 0-100, where 0=completely dissatisfied and 100=completely satisfied, after completing a series of real world tasks.
|
Day 1
|
|
Ocular aberrometry
Prazo: Day 1
|
Ocular aberrometry as measured by a LADARWave aberrometer
|
Day 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lyndon Jones, PhD, CCLR, University of Waterloo
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20067
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