ORYOM Robotic Surgical System in Cataract Surgery

March 9, 2026 updated by: ForSight Robotics Ltd

Single-site, Open-label, Prospective Feasibility Study Performed Using the ORYOM™ Robotic Surgical System in Cataract Surgery Procedures

This is a prospective, open-label clinical study designed to evaluate the performance and safety of the ORYOM Robotic Surgical System during cataract surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Philippines
    • National Capital Region
      • Makati City, National Capital Region, Philippines, 1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ORYOM™ Robotic Surgical System
Subjects will undergo cataract surgery using the ORYOM Robotic Surgical System.
Device: ORYOM™ Robotic Surgical System
The ORYOM Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful completion of planned Robotic-Assisted cataract surgery
Time Frame: Intra-operative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From surgery through 30 days post-procedure
Incidence and type of all AEs and SAEs occurring intraoperatively and during the postoperative follow-up period.
From surgery through 30 days post-procedure
Distribution of pre and postoperative Best Corrected Visual acuity
Time Frame: Baseline and up to 30 days post-procedure
Distribution of preoperative and postoperative BCVA
Baseline and up to 30 days post-procedure
Postoperative Ophthalmic examination findings
Time Frame: Up to 30 days post-procedure
Postoperative slit lamp and dilated fundus examinations findings
Up to 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ForSight Robotics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPH000003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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