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Dry AMDMAIAStudNCT07170683

Microperimetry Changes in Retinal Function in Macular Disorders

An observational study of Dry AMD and Diabetic Retinopathy (DR), run by University of Nottingham at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to measure precisely how sensitive the central part of the retina - the light-sensitive film at the back of the eye, is to light. We will use a special device called the Macular Integrity Assessment (MAIA) microperimetry (MP) system to achieve this, particularly for individuals with… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Dry AMD, Diabetic Retinopathy (DR)
What is being tested?
MAIA Microperimetry, Microperimetry and Visual Acuity Measurement (logMAR)
Type of treatment
Medical device
How many people
200 participants
Where
1 siteUnited Kingdom
Study dates
4 Apr 2025to 30 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be recruited from the Medical Retina and Macular clinics of the Queen's Medical Centre. Healthy controls will be recruited from persons accompanying patients to the Eye Clinic, hospital and University staff. Healthy volunteers who are accompanying persons to the clinic will be approached after the patient participant has been approached.

Who may be able to join

  • Adult age above 21 years old.
  • Signed informed consent
  • Visual acuity Log MAR 0.0 to 1.2
  • Patients diagnosed with:
  • Geographic atrophy (AMD).
  • Diabetic without retinopathy, and minimal to moderate non-proliferative diabetic retinopathy (NPDR) with or without presence of macular oedema on optical coherence tomography (OCT)
  • Control group of age matched participants without any retinal disease, glaucoma or optic nerve disease in either eye Patients willing to attend follow-up MP examinations. (This does not apply to normal controls who only require one attendance).

Who cannot join

  • Moderate to severe cataract (over grade 2) or other cause of opaque optical media that will preclude adequate fundoscopy or MP assessment.
  • Previous treatments in the eye with intravitreal therapies of anti-VEGFs or steroids within the previous 6 months, or macular laser photocoagulation
  • Active vascular event in either eye any examination time.
  • Participants who are unable/unwilling to provide consent
  • Participants who are unable to read English fluently
  • Normal Controls Inclusion Criteria
Show all 17Show fewer
  • Normal controls will include persons who are not diabetic, and do not have glaucoma, any retinal or optic nerve disease.
  • Signed informed consent
  • Adult age above 21 years old. No upper age limit.
  • Visual acuity LogMAR <0.2.
  • Controls should be willing to attend once only.
  • Moderate to severe cataract (over grade 2) or other cause of opaque optical media
  • Previous treatments in the particular eye with intravitreal therapies of anti-VEGFs or steroids within the previous 6 months, or macular laser photocoagulation
  • Active/previous vascular event in either eye e.g. retinal arterial or vein occlusion, ischaemic optic neuropathy, or glaucoma
  • Persons with diabetes
  • Participants who are unable to read English fluently
  • Participants who are unable/unwilling to provide consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • Nottingham University Hospitals NHS Trust

    Nottingham, Notts, NG7 2UH

Other trials in United Kingdom

About this study

Official title: An Investigation of Microperimetry for Monitoring Retinal Function in Selected Macular Disorders

The purpose of this study is to measure precisely how sensitive the central part of the retina - the light-sensitive film at the back of the eye, is to light. We will use a special device called the Macular Integrity Assessment (MAIA) microperimetry (MP) system to achieve this, particularly for individuals with specific retinal conditions. The macula (with the fovea at its very centre) is the part of the retina responsible for our fine detailed vision, colour vision, and maintaining steady gaze on objects (called 'fixation'). Diseases that affect the macula lead to difficulties in seeing clearly.

Macular sensitivity refers to how responsive the macula is to light, including the ability to read and focus on objects. This also determines how well the eye can maintain a steady gaze on objects of interest ('fixation'). While standard eye tests primarily measure vision in the fovea, measuring sensitivity across the wider macula would provide a more complete picture of visual function. Furthermore, we believe that macular sensitivity changes are often one of the earliest signs of retinal diseases, before a person experiences blurry vision. Currently, MP is not used routinely in UK NHS clinical practice.

Read more

The commonest retinal diseases are age-related macular degeneration (AMD) and diabetic retinopathy (DR). There are 2 types of AMD: dry and wet.

  • Dry AMD is a condition that affects the central part of the retina (the macula) and can lead to gradual vision loss as people age. This is due to wearing out and loss of the slight sensitive cells in the macula that can make it harder to see fine details, such as reading or recognizing faces.
  • Diabetic retinopathy means that diabetes has affected the blood vessels in the retina. In the early stages, the affected blood vessels do not leak. However, progression results in leakage of the blood vessels in the retina, leading to retinal swelling (called diabetic macular oedema [DMO]). Eyes with DMO function less well compared to when there is no swelling.

It is important to investigate these selected common conditions further, in order to find ways of detecting changes earlier, before the patient notices any abnormalities. Such earlier detection may result in better understanding and treatments in the future.

The main goal of this research is to measure macular sensitivity and ability to maintain a steady gaze on specific objects or points in patients with these macular disorders using the MAIA device. These measurements will be compared to changes in the structure of the macula, obtained using advanced imaging techniques like optical coherence tomography (OCT) and OCT angiography (OCTA), which are routinely used in standard clinical practice.

This study will form part of a research/educational thesis, and provide additional data to complement previous research on the topic.

Participants (after consent) will have MP done. In addition, we will assess information from their eye clinic records, including images and scans of the back of the eyes (OCT and OCTA). No treatment interventions are planned as part of this study. Participants standard of care will not be affected.

Participants will have tests done at baseline, and repeated at 6 and 12 months. In addition, we will invite a group of normal controls (i.e. persons who do not have any diseases of the back of their eyes) for comparison. This will ensure validity of our findings. The normal controls will attend only once (at baseline). After consent is obtained, these healthy participants will have MP, and imaging of the macula with OCT.

Being tested
MAIA Microperimetry, Microperimetry, Visual Acuity Measurement (logMAR), OCT-A
Keywords
retinal sensitivity, microperimetry, diabetic retinopathy, dry AMD, OCT, OCT-A, geographic atrophy
Medical subject headings
Diabetic Retinopathy, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAIA MicroperimetryOther

    Microperimetry (MP) is not performed as part of the current NHS patient pathway. We plan testing 2 MP strategies ('standard' vrs 'fast') to determine whether the fast testing strategy is as robust as the standard test strategy. Adopting the fast strategy will reduce time spent on the MP machine to obtain relevant test results. Healthy volunteers (with no retinal disease) are necessary for comparison, and to establish validity of any new findings.

  • MicroperimetryDevice

    Two fully automatic MAIA MP (CenterVue, spa; Padova, Italy) examinations (to obtain retinal sensitivity) shall be performed over the 10° diameter central retinal area for the recruited study participants. The first one will be performed with a fast projection, and the second one with the standard full 4-2 staircase projection strategy. Identification of the PRL area will be automatically calculated at the end of each examination. All patient groups will have identical assessment, at all time points. Healthy volunteers will only have assessments at baseline (one examination only)..

  • Visual Acuity Measurement (logMAR)Other

    Visual acuity will be measured with the ETDRS chart, and with the participant habitual distance correction, and recorded in logMAR notation

  • OCT-ADevice

    OCT and OCT-A examination, as well FAF will be undertaken with the Topcon Triton Plus OCT

Study groups in NCT07170683
Study groupRoleWhat they receive
Participants with dry AMD (including geographic atrophy [GA])Participants with dry AMD including GA. MP will be performed in 2 different modalities, a full staircase threshold stimuli projection, and a simplified stimuli projection of 4 fixed levels of stimuli intensity. OCT and OCT-A will be done with the Topcon Triton. Best habitual corrected distance VA (logMAR) will be recorded.
Receives: Other: MAIA Microperimetry; Device: Microperimetry; Other: Visual Acuity Measurement (logMAR); Device: OCT-A
Persons with diabetes without diabetic retinopathyParticipants with diabetes without diabetic retinopathy. MP will be performed in 2 different modalities, a full staircase threshold stimuli projection, and a simplified stimuli projection of 4 fixed levels of stimuli intensity. OCT and OCT-A will be done with the Topcon Triton. Best habitual corrected distance VA (logMAR) will be recorded.
Receives: Other: MAIA Microperimetry; Device: Microperimetry; Other: Visual Acuity Measurement (logMAR); Device: OCT-A
Participants with diabetes with mild to moderate diabetic retinopathy (i.e. non-proliferative DR)..Participants with diabetes with mild to moderate diabetic retinopathy. MP will be performed in 2 different modalities, a full staircase threshold stimuli projection, and a simplified stimuli projection of 4 fixed levels of stimuli intensity. OCT and OCT-A will be done with the Topcon Triton. Best habitual corrected distance VA (logMAR) will be recorded.
Receives: Other: MAIA Microperimetry; Device: Microperimetry; Other: Visual Acuity Measurement (logMAR); Device: OCT-A
Normal (healthy) controlsNormal controls will include persons who are not diabetic, and do not have glaucoma, any retinal or optic nerve disease. MP will be performed in 2 different modalities, a full staircase threshold stimuli projection, and a simplified stimuli projection of 4 fixed levels of stimuli intensity. OCT and OCT-A will be done with the Topcon Triton. Best habitual corrected distance VA (logMAR) will be recorded.
Receives: Other: MAIA Microperimetry; Device: Microperimetry; Other: Visual Acuity Measurement (logMAR); Device: OCT-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlations of retinal sensitivity (dB) changes over time, compared with OCT/OCTA measures (change in retinal/choroidal thickness in microns and/or %; % change in choroidal vascularity)

    Retinal sensitivity (dB) will be measured with MP. Correlations will be made between retinal sensitivities between each group and normal controls, and over time.

    Measured: from enrolment (baseline) to 6 and 12 months

  2. MP BCEA values

    Correlations of changes in BCEA (fixation stability in degrees: BCEA@63 and BCEA@95) in the different groups will be analysed similarly, and over time, using a mixed-effects model to account for variability between eyes and between subjects. Quantify deviations from baseline PRL in degrees.

    Measured: Baseline compared to 6 and 12 months

Secondary outcomes (1)
  1. Baseline factors relationship to retinal sensitivity (dB) with age (years), disease duration (years) and baseline visual acuity (LogMAR)

    Relationship of baseline factors (e.g., age [years], disease duration [years], baseline visual acuity [logMAR]) are predictive of outcomes in retinal sensitivity (dB), fixation stability (BCEA), or fixation (PRL) location. Statistical correlations will be made of retinal sensitivities (dB) between each group(dry AMD, no DR, DR) and normal controls, and over time

    Measured: baseline, changes from baseline to 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2025
  2. Study start4 Apr 2025
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07170683
Sponsor's protocol ID
24060
Acronym
MAIAStud
Status last verified
Aug 2025
First submitted
8 Jul 2025
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dry AMD and Diabetic Retinopathy (DR), run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlations of retinal sensitivity (dB) changes over time, compared with OCT/OCTA measures (change in retinal/choroidal thickness in microns and/or %; % change in choroidal vascularity) (time frame: from enrolment (baseline) to 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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