Study of Dark Adaptation in Age-Related Macular Degeneration
Кључне речи
Апстрактан
Опис
Objective: This study is designed to investigate the use of dark adaptation as a functional endpoint for progression of eyes with no to intermediate age-related macular degeneration (AMD).
Study Population: Two hundred forty (240) participants will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. Participants will have varying degrees of severity of AMD (Groups 0, 1, 2, 3 and 4). Group 0 (N=40) is defined as participants without AMD meaning no large drusen (greater than or equal to 125 microns) or advanced AMD in either eye. Group 1 (N=40) is defined as participants with large drusen (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD (choroidal neovascularization (CNV) or geographic atrophy (GA)) in the fellow eye. Group 2 (N=40) is defined as participants with bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes. Group 3 (N=40) is defined as participants with large drusen (greater than or equal to 125 microns) in the study eye and advanced AMD (CNV or GA) in the fellow eye. Group 4 (N=40) is defined as participants with findings of reticular pseudodrusen (RPD) defined as having (1) the presence of reticular inter-lacing patterns on at least one en face imaging method (color photography, autofluorescence or infrared) and (2) confirmation of previously described findings of hyperreflective material located between the retinal pigment epithelium (RPE) and the photoreceptor ellipsoid zone on SD OCT in those areas. Current participants in this study have been graded and categorized into this cohort. Up to 40 diabetic participants will be recruited.
Design: This is a single center, exploratory, observational, longitudinal evaluation of dark adaptation response in AMD participants over five years and long-term evaluation of dark adaptometry (DA) change as a predictor for AMD progression and visual acuity (VA) loss.
Outcome Measures: The primary outcome is to determine mean change, including the distribution of change, in dark adaptation response between baseline and months 12 and 24 for Groups 0, 1, 2, 3 and 4. The secondary outcomes for each of the five groups are to determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60 and to determine mean change in best-corrected visual acuity (BCVA) of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60. Exploratory outcomes for each of the five groups are to correlate mean BCVA of the study eye with mean dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60 and to correlate AMD severity with dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60. Images from all visits may be sent to the Reading Center; however, only the baseline and annual visits are required to be graded. This study will also analyze renal function in AMD participants. Additionally, exploratory analysis of the small sample of diabetic participants will also be performed.
Датуми
| Последња верификација: | 08/25/2020 |
| Фирст Субмиттед: | 05/10/2011 |
| Предвиђена пријава послата: | 05/10/2011 |
| Прво објављено: | 05/11/2011 |
| Послато последње ажурирање: | 09/02/2020 |
| Последње ажурирање објављено: | 09/03/2020 |
| Стварни датум почетка студије: | 05/15/2011 |
Стање или болест
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Group 0 participants without AMD (no large drusen or advanced AMD in either eye) | |
| Group 1 Participants with large drusen in the study eye and no large drusen or advanced AMD or GA in the fellow eye. | |
| Group 2 Participants with bilateral large drusen with or without retinal pigment epithelial hypo/hyperpigmentary changes | |
| Group 3 Participants with large drusen in the study eye and advanced AMD (CNV or GA) in the fellow eye | |
| Group 4 Participants with findings of RPD |
Критеријуми
| Узраст подобан за студирање | 50 Years До 50 Years |
| Полови подобни за студирање | All |
| Метода узорковања | Non-Probability Sample |
| Прихвата здраве волонтере | да |
| Критеријуми | - INCLUSION CRITERIA: Participants will be eligible if the following inclusion criteria are met: - Participant is able to understand and sign the protocol s informed consent document. - Participant is able to complete and comply with study assessments for the full duration of the study. - Participant is greater than or equal to 50 years of age. - Participant has a BCVA score of greater than or equal to 20/100 (Snellen equivalent) in study eye. - Participant qualifies for one of the following groups based on AMD grading as defined below. - Group 0: Participant without AMD defined as no large drusen or advanced AMD in either eye; - Group 1: Participant has at least one large drusen (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye; - Group 2: Participant has bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes; - Group 3: Participant has at least one large drusen (greater than or equal to 125 microns) in the study eye and advanced AMD in the fellow eye. - Group 4: Participant has reticular pseudodrusen in the study eye defined as having the presence of RPD on at least one en face imaging method (color photography, autofluorescence or infrared) and (2) confirmation of previously described findings of hyperreflective material located between the RPE and the photoreceptor ellipsoid zone on SD OCT in those areas. EXCLUSION CRITERIA: Participants who meet any of the following criteria will be excluded from this study: - Participant has advanced AMD in the study eye at the baseline visit. - Participant has other active ocular or macular diseases (e.g., diabetic macular edema, retinal vein occlusion, Stargardt s disease or cone-rod dystrophy) or other known ocular disorders that have caused a visual field deficit (e.g., glaucoma with known visual field defect) in the study eye. - Participant has a fixation deficit in the study eye that would prevent the participant from performing the AdaptDxTM dark adaptation protocol. - Participant has a medical condition that the investigator feels would prevent the participant from complying with or being able to complete the study assessments - Participant had cataract surgery in the study eye within three months prior to enrollment. - Participant has an oral intake of high doses of vitamin A palmitate supplement (greater than or equal to 10,000 international units (IU) per day). - Participant has or had hepatitis or liver disease. Abnormally low vitamin A can alter dark adaptation and chronic liver disease has been associated with low vitamin A. - Participant has a history of vitamin A deficiency. - Participant is an NEI employee or subordinate or co-worker of an investigator. |
Исход
Примарне мере исхода
1. The primary outcome is to determine mean change, including the distribution of change, in dark adaptation response between baseline and months 12 and 24 for Groups 0-4. [Month 12 and Month 24]
Секундарне мере исхода
1. To determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60. [Baseline, months 3,6,18,36,48 and 60]
2. To determine mean BCVA of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60. [Baseline, months 3,6,12,18,24,36,48 and 60]
