ORYOM Robotic Surgical System in Cataract Surgery
Single-site, Open-label, Prospective Feasibility Study Performed Using the ORYOM™ Robotic Surgical System in Cataract Surgery Procedures
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a prospective, open-label clinical study designed to evaluate the performance and safety of the ORYOM Robotic Surgical System during cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2026
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
March 12, 2026
March 1, 2026
12 months
March 5, 2026
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Successful completion of planned Robotic-Assisted cataract surgery
Proportion of study eyes in which the planned robotic cataract surgery is completed using the ORYOM Robotic Surgical System without conversion to manual technique.
Intra-operative
Secondary Outcomes (3)
Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From surgery through 30 days post-procedure
Distribution of pre and postoperative Best Corrected Visual acuity
Baseline and up to 30 days post-procedure
Postoperative Ophthalmic examination findings
Up to 30 days post-procedure
Study Arms (1)
ORYOM™ Robotic Surgical System
EXPERIMENTALSubjects will undergo cataract surgery using the ORYOM Robotic Surgical System.
Interventions
The ORYOM Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asian Eye Instiitute
Makati City, National Capital Region, 1200, Philippines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 12, 2026
Study Start
February 20, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared at this time due to privacy, confidentiality, and regulatory considerations. Future sharing may be considered under appropriate agreements and conditions.