Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03492853
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2018-04-02
Brief Title:
The Association of the Peripheral Retinal Changes and Genotypic Changes in Patients With Age Related Macular Degeneration
Sponsor:
University Hospital Sestre Milosrdnice
Organization:
University Hospital Sestre Milosrdnice
Study Overview
Official Title:
The Association of the Peripheral Retinal Changes and Genotypic Changes in Patients With Age Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose To examine the genotypes associated with the peripheral retinal phenotypic features in patients with age-related macular degeneration documented with wide-field imaging
Design Clinic-based case series study in Croatia Participants 160 patients 50 years of age known to have early or advanced AMD and 150 subjects 50 years of age without known AMD controls Methods Both groups of patients were examined with ophthalmoscopy and OCT to confirm their classification Posterior and peripheral fundus features were documented with Optos wide-field imaging Optos P200MA Optos Plc Dunfermline Scotland and graded DNA was extracted from blood samples and gene polymorphisms were evaluated for complement factor H CFH rs1061170 and rs1410996 age-related maculopathy susceptibility ARMS2 rs10490924 high temperature requirement factor A1 HtrA1 rs11200638 complement factor B CFB rs4151667 and rs641153 complement factor 2 C2 rs9332739 and rs547154 and complement factor 3 C3 rs2230199
Design Clinic-based case series study in Croatia Participants 160 patients 50 years of age known to have early or advanced AMD and 150 subjects 50 years of age without known AMD controls Methods Both groups of patients were examined with ophthalmoscopy and OCT to confirm their classification Posterior and peripheral fundus features were documented with Optos wide-field imaging Optos P200MA Optos Plc Dunfermline Scotland and graded DNA was extracted from blood samples and gene polymorphisms were evaluated for complement factor H CFH rs1061170 and rs1410996 age-related maculopathy susceptibility ARMS2 rs10490924 high temperature requirement factor A1 HtrA1 rs11200638 complement factor B CFB rs4151667 and rs641153 complement factor 2 C2 rs9332739 and rs547154 and complement factor 3 C3 rs2230199
Detailed Description:
Purpose To examine the genotypes associated with the peripheral retinal phenotypic features in patients with age-related macular degeneration documented with wide-field imaging
Design Clinic-based case series study in Croatia Participants Using standard protocols 160 patients 50 years of age known to have early or advanced AMD and 150 subjects 50 years of age without known AMD controls were studied
Materials and methods Both groups of patients were examined with ophthalmoscopy and OCT to confirm their classification Posterior and peripheral fundus features were documented with Optos wide-field imaging Optos P200MA Optos Plc Dunfermline Scotland and graded DNA was extracted from blood samples and gene polymorphisms were evaluated for complement factor H CFH rs1061170 and rs1410996 age-related maculopathy susceptibility ARMS2 rs10490924 high temperature requirement factor A1 HtrA1 rs11200638 complement factor B CFB rs4151667 and rs641153 complement factor 2 C2 rs9332739 and rs547154 and complement factor 3 C3 rs2230199
The study cohort was identified among the clinical patients at the University Department of Ophthalmology at University Hospital Centre Sestre milosrdnice Zagreb Croatia The protocol was approved by the Ethics Committee approval EP-1303011-13 of the University Hospital Centre Sestre milosrdnice and complied with the tenets of the Declaration of Helsinki with the informed consent obtained from all the participants We included 160 subjects in AMD group and 150 subjects in the control group who met the following criteria age exceeding 50 years clinical signs of AMD in at least one eye in AMD group and without signs of the disease in the control group Exclusion criteria were as follows confounding maculopathy of any etiology having a myopic refractive error more than -30 diopters in either eye failure to obtain readable color images documenting at least 270 degrees of the retina three quadrants or failure to provide a peripheral blood sample for DNA extraction All the participants were examined according to standardized examination protocols where the macular region and retinal periphery were photodocumented with Resmax and wide field imaging respectively using the Optos P200MA camera Optos plc Dumfermline Scotland23 Phenotypes Eligibility for the AMD group was determined according to an international classification of AMD2425 The retinal periphery was defined as an extramacular area 6000 µm diameter distant from the foveolar centre and a grid template was used for measuring the distance Following peripheral retinal phenotypes were documented peripheral drusen reticular pigmentations RP hyperpigmentations pigment clumping PC or nevus N hypopigmentations peripheral retinal pigment defects RPD or atrophic areas AA other degenerations in aggregate OD which include any of the following microcystoid degenerations with degenerative retinoschisis RD lattice degenerations LD snail-track degeneration ST white-without pressure WWP paving stone degenerationalso known as cobblestone PS retinal holes R and vitreal opacities VO The inclusion criteria for the peripheral retinal change was its size which had to exceed at least one hour of the retinal periphery Main outcome measures The type localization and frequency of peripheral retinal changes and gene polymorphisms of participants in both groups were examined
Design Clinic-based case series study in Croatia Participants Using standard protocols 160 patients 50 years of age known to have early or advanced AMD and 150 subjects 50 years of age without known AMD controls were studied
Materials and methods Both groups of patients were examined with ophthalmoscopy and OCT to confirm their classification Posterior and peripheral fundus features were documented with Optos wide-field imaging Optos P200MA Optos Plc Dunfermline Scotland and graded DNA was extracted from blood samples and gene polymorphisms were evaluated for complement factor H CFH rs1061170 and rs1410996 age-related maculopathy susceptibility ARMS2 rs10490924 high temperature requirement factor A1 HtrA1 rs11200638 complement factor B CFB rs4151667 and rs641153 complement factor 2 C2 rs9332739 and rs547154 and complement factor 3 C3 rs2230199
The study cohort was identified among the clinical patients at the University Department of Ophthalmology at University Hospital Centre Sestre milosrdnice Zagreb Croatia The protocol was approved by the Ethics Committee approval EP-1303011-13 of the University Hospital Centre Sestre milosrdnice and complied with the tenets of the Declaration of Helsinki with the informed consent obtained from all the participants We included 160 subjects in AMD group and 150 subjects in the control group who met the following criteria age exceeding 50 years clinical signs of AMD in at least one eye in AMD group and without signs of the disease in the control group Exclusion criteria were as follows confounding maculopathy of any etiology having a myopic refractive error more than -30 diopters in either eye failure to obtain readable color images documenting at least 270 degrees of the retina three quadrants or failure to provide a peripheral blood sample for DNA extraction All the participants were examined according to standardized examination protocols where the macular region and retinal periphery were photodocumented with Resmax and wide field imaging respectively using the Optos P200MA camera Optos plc Dumfermline Scotland23 Phenotypes Eligibility for the AMD group was determined according to an international classification of AMD2425 The retinal periphery was defined as an extramacular area 6000 µm diameter distant from the foveolar centre and a grid template was used for measuring the distance Following peripheral retinal phenotypes were documented peripheral drusen reticular pigmentations RP hyperpigmentations pigment clumping PC or nevus N hypopigmentations peripheral retinal pigment defects RPD or atrophic areas AA other degenerations in aggregate OD which include any of the following microcystoid degenerations with degenerative retinoschisis RD lattice degenerations LD snail-track degeneration ST white-without pressure WWP paving stone degenerationalso known as cobblestone PS retinal holes R and vitreal opacities VO The inclusion criteria for the peripheral retinal change was its size which had to exceed at least one hour of the retinal periphery Main outcome measures The type localization and frequency of peripheral retinal changes and gene polymorphisms of participants in both groups were examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None