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JASPER™ Robotic Surgical System (Formerly Known as the ORYOM™ Robotic Surgical System) in Cataract Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07468409
Enrollment
40
Registered
2026-03-12
Start date
2026-02-20
Completion date
2027-04-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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

Interventions

DEVICEJASPER™ Robotic Surgical System

The JASPER™ Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery.

Sponsors

ForSight Robotics Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Successful completion of planned Robotic-Assisted cataract surgeryIntra-operativeProportion of study eyes in which the planned robotic cataract surgery is completed using the JASPER™ Robotic Surgical System without conversion to manual technique.

Secondary

MeasureTime frameDescription
Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs)From surgery through 30 days post-procedureIncidence and type of all AEs and SAEs occurring intraoperatively and during the postoperative follow-up period.
Distribution of pre and postoperative Best Corrected Visual acuityBaseline and up to 30 days post-procedureDistribution of preoperative and postoperative BCVA
Postoperative Ophthalmic examination findingsUp to 30 days post-procedurePostoperative slit lamp and dilated fundus examinations findings

Countries

Philippines

Contacts

CONTACTMerav Gat, M.Sc., MBA
merav.gat@forsightrobotics.com+972547800259

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026