Home CRYSTALSIGHT gaze-tracking for monitoring maculopathy after anti-VEGF treatment
CRYSTALSIGHT: Clinical Evaluation of OCCUTRACK's CRYSTALSIGHT Device Through Remote Monitoring for Disease Recurrence of Wet Aged-Related Macular Degeneration Using Eye Gaze Tracking (Cohort 2.0).
This will test whether the CRYSTALSIGHT home gaze-tracking device helps people aged 55–99 who finished anti‑VEGF injections for wet AMD or diabetic macular edema spot vision changes sooner than standard clinic follow-up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years to 99 Years |
| Sex | All |
| Sponsor | Tan Tock Seng Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07255859 on ClinicalTrials.gov |
What this trial studies
Adults aged 55–99 with previous wet AMD or diabetic macular edema who have completed anti‑VEGF therapy and show no active recurrence will be randomized to standard PRN care or PRN care plus CRYSTALSIGHT home monitoring. CRYSTALSIGHT is a portable, self‑administered gaze‑tracking device that the team previously validated against in‑hospital OCT measurements. Participants will perform regular home tests and clinicians will be alerted to central metamorphopsia signals that could prompt clinic review and imaging. The trial compares detection timing, visit frequency, retreatment timing, and cost‑effectiveness between the two arms at a single center.
Who should consider this trial
Good fit: Ideal candidates are people aged 55–99 with prior wet AMD or diabetic macular edema who have finished anti‑VEGF injections, currently show no active recurrence, and can use the device and communicate in English, Chinese, or Bahasa Melayu.
Not a fit: Patients who cannot operate the device independently, have active recurrent disease or severe vision impairment, or cannot use the supported languages are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, patients could get earlier detection of recurrence, faster retreatment when needed, and fewer routine clinic visits.
How similar studies have performed: Other home‑monitoring systems for AMD have shown promise for earlier detection, and CRYSTALSIGHT has prior validation against hospital OCT measurements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects in the age group ≥ 55 to 99 years old. 2. Both genders 3. Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation. 4. Able to turn on and connect the CRYSTALSIGHT device to a computer independently or with the help of family. 5. Subjects undergoing treatment for Wet-AMD without any signs and symptoms of recurrence of active AMD (AMD recurrence: choroidal neovascularisation, intraretinal or subretinal fluid is present) with OCT lesion fluid volume more than 2 mm2 or ILM height more than 300µm. 6. Ability to comply with the study protocol, in the investigator's judgment. 7. Subjects must be able to understand and provide informed consent. A signed informed consent form must be provided before any study assessments. Exclusion Criteria: 1. Unable to understand verbal spoken instructions and demonstrate device functionality and implementation. 2. Unable to turn on and connect the CRYSTALSIGHT device to a computer independently. 3. Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months 4. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye 5. Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study 6. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye. 7. History of idiopathic or autoimmune-associated uveitis in either eye 8. Active ocular inflammation or suspected or active ocular or periocular infection in either eye.
Where this trial is running
Singapore
- Tan Tock Seng Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA — Tan Tock Seng Hospital
- Study coordinator: Zheng Kuang, Noel Soh, BSc
- Email: zheng.Kuang.soh@nhghealth.com.sg
- Phone: +65 6357 3693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.