Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA). (FCPGA-2025)

The study will prospectively recruit patients from the Retina Clinics at the John A. Moran Eye Center and its satellite clinics.

All team members will be trained and certified for their specific tasks to ensure that uniform procedures are followed in order to obtain comparable and reliable data.

The following study procedures will be performed after informed consent has been obtained (in chronologic order):

• Assessment of past and current ophthalmic history, and demographic details
• Best-corrected visual acuity (BCVA) for both eyes measured by Early Treatment Diabetic Retinopathy Study (ETDRS) or Snellen charts (performed at Visit [V]1, V2, V4 and V6)

• Fundus-controlled perimetry (FCP)

  • Training Test (performed at V1, V2, V3, V4, V5, V6)
  • Fixes macula pattern (performed at V1 and V6)
  • Patient-tailored pattern (performed at V2 [twice for test - re-test assessment], V3, V4, V5, V6)
• Vision Impairment in Low Luminance with 33 items (VILL-33), a 33-item questionnaire (performed at V2, V4, and V6)
• Fundus autofluorescence (FAF), near infrared (NIR) and simultaneous spectral domain optical coherence tomography (SD-OCT) imaging (performed at V1, V4 and V6)
• Color digital fundus photographs (optional at visits V1, V4, and V6)
• OCT-angiography (OCT-A) imaging (optional at visits V1, V4 and V6)

Data to be obtained and analyzed will include each participant's medical and ophthalmic history, current medications, smoking history, body mass index (BMI), and demographic information. Additional research data will include records of any adverse events, functional testing results such as best-corrected visual acuity (BCVA) and fundus-controlled perimetry (FCP), and digital imaging data including color fundus photographs, fundus autofluorescence (FAF) images, near-infrared reflectance (NIR) images, optical coherence tomography (OCT) images, and optical coherence tomography angiography (OCT-A) images.

Study data and documentation will be monitored throughout the study to ensure accuracy, completeness, and compliance with the approved protocol, Good Clinical Practice (GCP) standards, and institutional policies. Monitoring procedures will include periodic review of informed consent documentation and verification that data recorded in study forms and electronic databases are consistent with source documents.

Data management and analysis will be conducted by the Utah Retinal Reading Center (UREAD). UREAD will develop comprehensive study-specific documentation, including a Data Management Manual and a Grading Manual, which will outline standardized protocols for data processing, grading procedures, and quality assurance.

Prior to initiating formal data analysis, all image graders will undergo standardized training and certification using curated training datasets. Each imaging dataset will be independently evaluated by two certified readers to ensure objectivity. In cases of disagreement, a senior grader will perform an arbitration review to determine the final grading outcome.

At the screening visit (V1), structural inclusion and exclusion criteria will be assessed to determine patient eligibility. The Reading Center will provide three types of FCP testing patterns in Extensible Markup Language (XML) format: Training Pattern; Fixed Central Macula Pattern; and a Patient-Tailored Pattern.

All imaging and test data will be securely transferred from the study site to UREAD for centralized grading and analysis. Quality control procedures will be implemented throughout the study to ensure data integrity and consistency.