Public trial
RBR-52r82gy Comparative study of donated corneas with and without Descemet's membrane in corneal transplants with perforation during...
Date of registration: 07/23/2024 (mm/dd/yyyy)Last approval date : 07/23/2024 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Comparison of donated corneas with and without Descemet's membrane in deep anterior lamellar corneal transplantation with intraoperative perforation
pt-br
Comparação de córneas doadas com e sem membrana de Descemet no transplante de córnea lamelar anterior profundo com perfuração intraoperatória
es
Comparison of donated corneas with and without Descemet's membrane in deep anterior lamellar corneal transplantation with intraoperative perforation
Trial identification
- UTN code: U1111-1310-6003
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Public title:
en
Comparative study of donated corneas with and without Descemet's membrane in corneal transplants with perforation during surgery
pt-br
Estudo comparativo entre córneas doadas com e sem membrana de Descemet em transplantes de córnea com perfuração durante a cirurgia
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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78346824.5.0000.0088
Issuing authority: Plataforma Brasil
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6.723.917
Issuing authority: Comitê de Ética em Pesquisa do Hospital Oftalmológico de Sorocaba
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78346824.5.0000.0088
Sponsors
- Primary sponsor: Hospital Oftalmológico de Sorocaba
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Secondary sponsor:
- Institution: Hospital Oftalmológico de Sorocaba
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Supporting source:
- Institution: Hospital Oftalmológico de Sorocaba
Health conditions
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Health conditions:
en
Cornea transplant status, Keratoconus, Corneal opacity, Cornea injuries
pt-br
Córnea transplantada, Ceratocone, Opacidade de córnea, Lesões de cornea
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General descriptors for health conditions:
en
H18 Other disorders of cornea
pt-br
H18 Outros transtornos da córnea
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Specific descriptors:
en
Z94.7 Cornea transplant status
pt-br
Z94.7 Córnea transplantada
en
C11.204.627 Keratoconus
pt-br
C11.204.627 Ceratocone
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C11.204.299 Corneal Opacity
pt-br
C11.204.299 Opacidade da cornea
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C10.900.300.284.250.124 Corneal Injuries
pt-br
C10.900.300.284.250.124 Lesões da Córnea
Interventions
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Interventions:
en
This is a prospective randomized comparative study that will be carried out at the Hospital Oftalmológico de Sorocaba (HOS) in patients undergoing deep anterior keratoplasty (DALK) who present intraoperative perforation of the recipient's Descemet's Membrane. They will be divided into two (2) groups. Group 1 will receive a donor cornea with Descemet's Membrane. Group 2 will receive donor cornea without Descemet's Membrane. Post-operative visits will take place at 1, 7, 30, 90, 180 and 360 days.
pt-br
Trata-se de um estudo prospectivo randomizado comparativo que será realizado no Hospital Oftalmológico de Sorocaba (HOS) em pacientes submetidos a ceratoplastia anterior profunda (DALK) que apresentem perfuração intraoperatória da Membrana de Descemet do receptor. Serão divididos em dois (2) grupos. O grupo 1 receberá cornea doadora com Membrana de Descemet. O grupo 2 receberá córnea doadora sem Membrana de Descemet. As visitas de pós operatório acontecerão com 1, 7, 30, 90, 180 e 360 dias.
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Descriptors:
en
E02.095.147.725.225 Corneal Transplantation
pt-br
E02.095.147.725.225 Transplante de Córnea
Recruitment
- Study status: Not yet recruiting
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Countries
- Brazil
- Date first enrollment: 08/15/2024 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 200 - 18 Y 0 -
Inclusion criteria:
en
Patients 18 years of age or older; patients indicated for deep anterior lamellar keratoplasty (DALK) by the Hospital Oftalmológico de Sorocaba (HOS); patients who agree to participate in the study
pt-br
Pacientes com 18 anos de idade ou mais; pacientes com indicação de transplante lamelar anterior profundo (DALK) pelo Hospital Oftalmológico de Sorocaba (HOS); pacientes que aceitem participar do estudo
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Exclusion criteria:
en
Patients who do not present intraoperative perforation of the Descemet's membrane; patients requiring conversion to penetrating keratoplasty (PK); pregnant or breastfeeding woman; patients who at some point give up participating
pt-br
Pacientes que não apresentem perfuração intraoperatória da membrana de Descemet; pacientes em que houve necessidade de conversão para ceratoplastia penetrante (PK; do inglês: Penetrating Keratoplasty); gestante ou lactante; pacientes que em algum momento desistam de participar
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Parallel 2 Single-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
It is expected to find a double anterior chamber increase in patients undergoing deep anterior lamellar transplantation (DALK) who had intraoperative perforation and received donor corneas with Descemet's Membrane (MD), proven by biomicroscopy and/or optical computed tomography (OCT) of anterior segment.
pt-br
Espera-se encontrar um aumento de dupla câmara anterior nos pacientes submetidos à transplante lamelar anterior profundo (DALK) que tiveram perfuração intraoperatória e receberam córneas doadoras com Membrana de Descemet (MD), comprovado por biomicroscopia e/ou tomografia ótica computadorizada (OCT) de segmento anterior.
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Secondary outcomes:
en
To compare the visual and topographic results and the complication rate of patients undergoing deep anterior lamellar transplantation (DALK) who had intraoperative perforation of the recipient's Descemet's Membrane (MD) and received donor corneas with or without Descemet's Membrane (MD), through visual acuity examination, biomicroscopy, corneal tomography, specular microscopy and contact lens testing.
pt-br
Comparar o resultado visual, topográfico e o índice de complicações dos pacientes submetidos à transplante lamelar anterior profundo (DALK) que tiveram perfuração intraoperatória da Membrana de Descemet (MD) do receptor e receberam córneas doadoras com ou sem Membrana de Descemet (MD), através do exame físico, biomicroscopia, tomografia de córnea, microscopia especular e teste de lente de contato.
Contacts
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Public contact
- Full name: José Alvaro Pereira Gomes
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- Address: Rua Botucatu, 822
- City: São Paulo / Brazil
- Zip code: 04023-062
- Phone: +55(11) 5085-2082
- Email: japgomes13@gmail.com.br
- Affiliation: Universidade Federal de São Paulo
- Full name: Constantin Philippe Salha
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- Address: Rua Joel Ribeiro, 330
- City: Sorocaba / Brazil
- Zip code: 18030-195
- Phone: +55(086)994908329
- Email: constantinsalha@gmail.com
- Affiliation: Hospital Oftalmológico de Sorocaba
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Scientific contact
- Full name: Constantin Philippe Salha
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- Address: Rua Joel Ribeiro, 330
- City: Sorocaba / Brazil
- Zip code: 18030-195
- Phone: +55(086)994908329
- Email: constantinsalha@gmail.com
- Affiliation: Hospital Oftalmológico de Sorocaba
- Full name: José Alvaro Pereira Gomes
-
- Address: Rua Botucatu, 822
- City: São Paulo / Brazil
- Zip code: 04023-062
- Phone: +55(11) 5085-2082
- Email: japgomes13@gmail.com.br
- Affiliation: Universidade Federal de São Paulo
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Site contact
- Full name: Constantin Philippe Salha
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- Address: Rua Joel Ribeiro, 330
- City: Sorocaba / Brazil
- Zip code: 18030-195
- Phone: +55(086)994908329
- Email: constantinsalha@gmail.com
- Affiliation: Hospital Oftalmológico de Sorocaba
- Full name: José Alvaro Pereira Gomes
-
- Address: Rua Botucatu, 822
- City: São Paulo / Brazil
- Zip code: 04023-062
- Phone: +55(11) 5085-2082
- Email: japgomes13@gmail.com.br
- Affiliation: Universidade Federal de São Paulo
Additional links:
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