Night vision test could spot early eye disease
NCT ID NCT01352975
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 9 times
Summary
This study looked at whether a simple test measuring how fast eyes recover in the dark can help track early to middle dry age-related macular degeneration (AMD). Researchers followed 217 adults aged 50 and older, with or without AMD, for up to 5 years. The goal was to see if changes in dark adaptation over time could signal disease progression, which may help develop future treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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217 people
The number who actually took part.
- Started
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May 2011
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Two hundred forty participants (240) will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to month 12, an additional participant will be accrued. A maximum of 40 non-diabetic participants per group will be accrued in order to obtain 200 non-diabetic participants for the primary outcome analysis. Every effort will be made to ensure 40 non-diabetic participants per group are accrued. Additionally, a maximum of 40 diabetic participants will be accrued across all groups for the exploratory outcome analysis.
- Ages
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50 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 \>= 50 years of age. * Participant has a BCVA score of \>= 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 (\>= 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye; * Group 2: Participant has bilateral large drusen (\>= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes; * Group 3: Participant has at least one large drusen (\>= 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 (1) 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 (\>= 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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