- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04907318
Comparison Between a Toric Monofocal and Multifocal Intraocular Lens
Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.
Visão geral do estudo
Descrição detalhada
This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Inclusion criteria for research participants.
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.
The demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.
The preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).
The intraoperative data will be the power of the implant and any complications, if applicable.
The postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).
4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.
Refractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.
Changes will determine its stability in the coronal plane around the visual axis.
The intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.
The record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Visp, Suíça, 3930
- Vista Alpina Eye Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included.
Exclusion Criteria:
To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
- Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
ANKORIS
Cataract surgery performed with POD26PAYT
|
|
FINEVISION TORIC
Cataract surgery performed with POD26PAYFT
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
To observe the rotational stability of the implant
Prazo: 6 Months
|
Observation of rotational stability of the implant
|
6 Months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Visual Acuity
Prazo: 6 Months
|
To assess the visual acuities with and without correction and the best refraction to assess the benefit of the implants
|
6 Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kristof Vandekerckhove, MD, Vista Alpina Eye Cente, Visp, Switzerland, 3930
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PHY PODT-POD FT
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Cataract surgery
-
Kocaeli Derince Education and Research HospitalKocaeli UniversityDesconhecidoRecuperação aprimorada após a cirurgia | Cirurgia de Coração AbertoPeru
-
University of AlbertaConcluídoObstrucao nasalCanadá
-
National Cancer Centre, SingaporeConcluídoDoenças da TireoideCingapura
-
University of TriesteConcluídoCâncer de mamaItália
-
University of Illinois at ChicagoEthicon Endo-SurgeryRetirado
-
Instituto Mexicano del Seguro SocialAinda não está recrutandoApendicite | Crianças, Somente | Recuperação aprimorada após a cirurgia
-
Assiut UniversityAinda não está recrutandoDoenças Esofágicas | Complicação de Esofagostomia
-
Ethicon Endo-SurgeryRescindidoObesidadeEstados Unidos, Alemanha
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationConcluídoCâncer de Pulmão de Células Não PequenasCanadá
-
Seoul National University HospitalJohnson & Johnson Medical CompaniesConcluídoCâncer de intestinoRepublica da Coréia