RECRUITINGINTERVENTIONAL
ORYOM Robotic Surgical System in Cataract Surgery
Single-site, Open-label, Prospective Feasibility Study Performed Using the ORYOM™ Robotic Surgical System in Cataract Surgery Procedures
About This Trial
This is a prospective, open-label clinical study designed to evaluate the performance and safety of the ORYOM Robotic Surgical System during cataract surgery.
Who May Be Eligible (Plain English)
Main Who May Qualify:
- Patient aged 55 to 80 years
- Willing and able to sign an willing to sign a consent form, 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 Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (1)
Asian Eye Instiitute
Makati City, National Capital Region, Philippines