PureSee EDOF Versus ZCB00 Monofocal IOLs in Mild-to-Moderate Glaucoma
Clinical Outcomes, Contrast Sensitivity, and Patient Satisfaction Following Bilateral PureSee EDOF Versus ZCB00 Monofocal IOL Implantation in Patients With Mild to Moderate Primary Open-Angle Glaucoma: An Ambispective Investigator-Initiated Trial
This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery in patients with mild to moderate primary open-angle glaucoma (POAG). Two cohorts are compared: patients with bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (EDOF IOL) and patients with bilateral implantation of the TECNIS ZCB00 monofocal IOL.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Melissa Hamann Wright, Study Staff
- Número de telefone: 2389 713-580-2500
- E-mail: Melissa.Wright@manneye.com
Locais de estudo
-
-
Texas
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Houston, Texas, Estados Unidos, 77004
- Mann Eye Institute
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Contato:
- Melissa Hamann Wright
- Número de telefone: 2389 713-580-2500
- E-mail: Melissa.Wright@manneye.com
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Investigador principal:
- Phillip Brunson, OD
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients aged 45 years and older who underwent bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00, with bilateral mild or moderate primary open-angle glaucoma.
Descrição
Inclusion Criteria:
Age ≥45 years. Prior bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00 on or after March 12, 2026.
Intended postoperative refractive target between plano and -0.50 D in each eye. No intentional monovision. Bilateral mild or moderate POAG according to AAO ICD-10 staging criteria. Reliable glaucoma visual field available within approximately 18 months before cataract surgery or study enrollment, when available.
Reliable optical coherence tomography examination within 6 months. Adequately controlled IOP and clinically stable glaucoma in the investigator's opinion.
Prior SLT is permitted. Concurrent MIGS at the time of cataract surgery is permitted when clinically indicated at the discretion of the treating surgeon.
Ability to complete the study-specific examination and questionnaires. Study visit occurring 3-18 months following second-eye cataract surgery.
Exclusion Criteria:
Severe POAG or glaucomatous visual field loss involving fixation. Secondary glaucoma, including pseudoexfoliative, pigmentary, angle-closure, neovascular, or uveitic glaucoma.
Glaucoma surgery other than eligible concurrent MIGS that may materially influence study outcomes.
Corneal pathology or irregular astigmatism affecting visual outcomes. Prior corneal refractive surgery. Macular or neuro-ophthalmic disease affecting visual function. Other ocular pathology expected to limit postoperative CDVA to worse than 20/30.
Inability to obtain reliable visual field testing when required for glaucoma characterization.
Intentional monovision. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
PureSee EDOF IOL cohort
Subjects with bilateral implantation of the TECNIS PureSee Intraocular Lens (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (toric and non-toric) at cataract surgery. |
|
TECNIS ZCB00 monofocal IOL cohort
Subjects with bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Distance visual acuity - binocular distance-corrected visual acuity (DCVA)
Prazo: 3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected visual acuity measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intermediate visual acuity - binocular distance-corrected intermediate visual acuity (DCIVA)
Prazo: 3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected intermediate visual acuity at 66 cm measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Contrast sensitivity - binocular, distance-corrected, photopic CSV-1000 contrast sensitivity without glare
Prazo: 3 to 18 months following second-eye cataract surgery
|
CSV-1000 contrast sensitivity at spatial frequencies of 3, 6, 12, and 18 cycles per degree, binocular, distance-corrected, photopic, without glare. |
3 to 18 months following second-eye cataract surgery
|
|
Spectacle independence at distance, intermediate, and near
Prazo: 3 to 18 months following second-eye cataract surgery
|
Patient-reported spectacle independence at distance, intermediate, and near. |
3 to 18 months following second-eye cataract surgery
|
|
Quality of vision and dysphotopsias
Prazo: 3 to 18 months following second-eye cataract surgery
|
Patient-reported quality of vision and dysphotopsias assessed with validated patient-reported outcome instruments including the AIOLIS Questionnaire. |
3 to 18 months following second-eye cataract surgery
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
Prazo: 3 to 18 months following second-eye cataract surgery
|
The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome. |
3 to 18 months following second-eye cataract surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Phillip Brunson, OD, Mann Eye Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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
- PB-26-02
Plano para dados de participantes individuais (IPD)
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