Robotic-assisted cataract surgery using the ORYOM system
Single-site, Open-label, Prospective Feasibility Study Performed Using the ORYOM™ Robotic Surgical System in Cataract Surgery Procedures
NA · ForSight Robotics Ltd · NCT07468409
This will test whether the ORYOM robotic system can safely help perform cataract surgery in adults aged 55 to 80.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | ForSight Robotics Ltd (industry) |
| Locations | 1 site (Makati City, National Capital Region) |
| Trial ID | NCT07468409 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label interventional study in which the ORYOM Robotic Surgical System is used during standard cataract operations. Adult patients scheduled for cataract extraction at a single center in Makati will undergo surgery with the robotic system and be followed for perioperative and short-term postoperative outcomes. Key enrollment criteria include age 55–80, clear intraocular media aside from the cataract, and adequate pupil dilation, while patients with prior ocular surgery, polar cataract, zonular instability, pseudoexfoliation, active infection, or uveitis are excluded. The study will record procedural performance metrics, intraoperative safety events, and routine postoperative visual and ocular health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults 55–80 years old with cataract who can dilate adequately, have no prior ocular surgery or significant anterior segment abnormalities, and meet general health criteria.
Not a fit: Patients with prior ocular surgery or trauma, polar cataract, zonular instability, pseudoexfoliation, active ocular infection or uveitis, or high anesthetic/surgical risk (ASA > 3) are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the system could increase surgical precision and reduce intraoperative complications, potentially improving visual outcomes.
How similar studies have performed: Robotic assistance in ophthalmic surgery is an emerging field with early feasibility reports showing improved instrument stability and precision, but large-scale proof of clinical benefit for cataract outcomes is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Main Inclusion Criteria: * Patient aged 55 to 80 years * Willing and able to sign an informed consent, attend the clinic and comply with all study procedures and the study protocol * Patients are scheduled to undergo cataract surgery * Clear intraocular media, other than cataract * Pupil dilate according to stand of care Main Exclusion Criteria: * Prior ocular surgery or trauma in the study eye * Polar cataract in the study eye * Zonular instability or significant anterior segment abnormalities * Active ocular infection or uveitis * Pseudoexfoliation (PXF) syndrome in either eye * ASA Physical Status Classification \> 3 * Participation in another clinical trial within 30 days
Where this trial is running
Makati City, National Capital Region
- Asian Eye Instiitute — Makati City, National Capital Region, Philippines (RECRUITING)
Study contacts
- Study coordinator: Merav Gat, M.Sc., MBA
- Email: merav.gat@forsightrobotics.com
- Phone: +972547800259
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.
Conditions: Cataract