Cataract
Conditions
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
The JASPER™ Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Successful completion of planned Robotic-Assisted cataract surgery | Intra-operative | Proportion of study eyes in which the planned robotic cataract surgery is completed using the JASPER™ Robotic Surgical System without conversion to manual technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From surgery through 30 days post-procedure | Incidence and type of all AEs and SAEs occurring intraoperatively and during the postoperative follow-up period. |
| Distribution of pre and postoperative Best Corrected Visual acuity | Baseline and up to 30 days post-procedure | Distribution of preoperative and postoperative BCVA |
| Postoperative Ophthalmic examination findings | Up to 30 days post-procedure | Postoperative slit lamp and dilated fundus examinations findings |
Countries
Philippines