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Trial record 4 of 6 for:    quasar

Evaluate the Quality of Life of Patients With AMD (QUASAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242083
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.

Condition or disease Intervention/treatment
Age-related Macular Degeneration Other: quality of life questionnaire

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration
Actual Study Start Date : August 8, 2017
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : December 3, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Primary atrophic AMD Other: quality of life questionnaire
quality of life questionnaire

Secondary atrophic AMD Other: quality of life questionnaire
quality of life questionnaire




Primary Outcome Measures :
  1. responses to a quality of life questionnaire [ Time Frame: Change compared with baseline score at month 6, month 12 and month 18 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
During an ophthalmology consultation, the clinician who has established the diagnosis of primary atrophic or secondarily atrophic AMD (defined in 1.1.2) proposes to the patient fulfilling the aforementioned eligibility criteria to participate in the study.
Criteria

Inclusion Criteria:

- For the 2 populations studied

  • Persons who have given consent to take part
  • Persons aged 50 years or older
  • Willing and able to attend all of the scheduled visits and evaluations
  • Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
  • Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors
  • Diagnosed for less than 3 years
  • MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m

For patients with secondary atrophic AMD

• Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection.

Exclusion Criteria:

General criteria

  • Persons without national health insurance cover
  • Physical or mental disability ruling out participation
  • Inability to sign the written consent form, adults under guardianship
  • Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
  • Adults under guardianship

General medical history

• Uncontrolled AHT

Ophthalmological history

  • Severe non-proliferative or proliferative diabetic retinopathy
  • Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery
  • Corneal disease that could impair vision
  • Monogenic macular dystrophy or toxic maculopathy
  • History of uveitis
  • Amblyopia of the eye concerned
  • Intraocular surgery in the 3 months preceding inclusion
  • History of cornea transplantation in the studied eye
  • Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine, tamoxifen, interferon (93), external radiotherapy of the face and neck

Ophthalmological examination

  • Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)
  • Active infection in either eye
  • Central anterior serous or active retinopathy in either eye
  • Choroid neo-vascularisation
  • Active serous retinal detachment
  • Refractive error less than -15D or more than +10D

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242083


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03242083    
Other Study ID Numbers: KAUFFMANN PCA 2016
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases