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Recruiting NCT07468409

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

No phase Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JASPER™ Robotic Surgical System.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: 55 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Philippines
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Successful completion of planned Robotic-Assisted cataract surgery [Time frame: Intra-operative]
Secondary outcome measures (3)
  • Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: 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]
  • Postoperative Ophthalmic examination findings [Time frame: Up to 30 days post-procedure]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Philippines · 1 center
  • Asian Eye Instiitute — Makati City

Identifiers

NCT: NCT07468409 · CPH000003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗