An Investigation of Vitamin A Palmitate Supplementation in Patients withAMD and/or Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
An Investigation of Vitamin A Palmitate Supplementation in Patients withAMD and/or Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
批准号:
10020044
负责人:
Catherine Cukras
金额:
$5.51万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
Adverse reactionsDark AdaptationEligibility DeterminationEnrollmentEventInvestigationKineticsMeasurementMeasuresOutcome MeasureParticipantPatient Outcomes AssessmentsPatientsQuestionnairesSupplementationTimeVisual Acuitydesignimprovedluminanceprimary outcomeprospectiveretinyl palmitatesecondary outcomestudy population
中文摘要
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英文摘要
Objective: The objective of this study is to investigate the potential efficacy of vitamin A palmitate
in improving dark adaptation in participants with reticular pseudodrusen (RPD) and abnormal dark
adaptation.
Study Population: Ten participants will be initially accrued, however, up to twenty participants
with RPD who meet the eligibility criteria may be enrolled. In the event that a participant
withdraws from the study prior to receiving two months of study supplementation for a reason
unrelated to an adverse reaction, an additional participant will be accrued. A maximum of ten
additional participants may be accrued in order to obtain ten participants for the primary outcome
analysis.
Design: This is a pilot, uncontrolled, prospective, single center study to investigate the potential
efficacy of vitamin A palmitate in improving dark adaptation in participants with AMD and
abnormal dark adaptation.
Outcome Measures: The primary outcome is the measurement of dark adaptation parameters
(thresholds and kinetics) by the following: dark adaptation times as measured by the AdaptDx
comparing before and after vitamin A palmitate and dark adaptation parameters as measured by
the Medmont comparing before and after vitamin A palmitate supplementation. The secondary
outcomes are changes in low luminance visual acuity (LLVA) and changes in patient reported
outcomes as measured by the low luminance questionnaire (LLQ).
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海外基金