Home CRYSTALSIGHT gaze-tracking for monitoring maculopathy after anti-VEGF treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Subjects in the age group ≥ 50 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 web-camera 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 mm3 or ILM height more than 250µm.
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 web-camera 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.