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

ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorForSight Robotics Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • JASPER™ Robotic Surgical System

    Device

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: JASPER™ Robotic Surgical SystemExperimental treatment 1 intervention

Trial outcomes

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 JASPER™ Robotic Surgical System without conversion to manual technique.

Time frame
Intra-operative

Secondary outcomes

1

Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence and type of all AEs and SAEs occurring intraoperatively and during the postoperative follow-up period.

Time frame
From surgery through 30 days post-procedure
2

Distribution of pre and postoperative Best Corrected Visual acuity

Distribution of preoperative and postoperative BCVA

Time frame
Baseline and up to 30 days post-procedure
3

Postoperative Ophthalmic examination findings

Postoperative slit lamp and dilated fundus examinations findings

Time frame
Up to 30 days post-procedure

Other outcomes

Sponsors and contacts

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