Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383754
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-03-20
Brief Title:
Clareon Intraocular Lens Stability in Vitrectomy Patients CLOVE Study
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Clareon Intraocular Lens Stability in Vitrectomy Patients CLOVE Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens IOL stability in vitrectomy patients The investigator plans to target the patients undergoing cataract surgery A randomized study will be conducted with 2 arms one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong
Detailed Description:
All patients will undergo standard phacoemulsification cataract extraction with Clareon IOL or Tecnis 1 IOL by an experienced cataract surgeon Followed by vitrectomy to treat either epiretinal membrane or vitreous hemorrhage
All patients returned for follow-up visits at 1 week 1 month and 6 months after surgery for ophthalmic assessments including
Visual acuity measured by Early Treatment of Diabetic Retinopathy Study ETDRS chart
Refraction
Axial movement and tilt measured by Pentacam OCULUS Optikgeräte GmbH Germany using the Sasaki method The Scheimpflug image of the horizontal cross-section and the vertical cross-section of the IOL will be selected for measurement Central ACD will be measured as the distance between the central corneal posterior endothelium to the anterior surface of IOL The subtraction in ACD between two visits indicated forward or backward axial movement of the IOL
Decentration will be measured from the center of the IOL anterior surface to the pupillary axis which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line
Tilt will be measured as the angle between the IOL axis and the perpendicular visual axis
Any surgical complications and post-op complications will be documented
All patients returned for follow-up visits at 1 week 1 month and 6 months after surgery for ophthalmic assessments including
Visual acuity measured by Early Treatment of Diabetic Retinopathy Study ETDRS chart
Refraction
Axial movement and tilt measured by Pentacam OCULUS Optikgeräte GmbH Germany using the Sasaki method The Scheimpflug image of the horizontal cross-section and the vertical cross-section of the IOL will be selected for measurement Central ACD will be measured as the distance between the central corneal posterior endothelium to the anterior surface of IOL The subtraction in ACD between two visits indicated forward or backward axial movement of the IOL
Decentration will be measured from the center of the IOL anterior surface to the pupillary axis which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line
Tilt will be measured as the angle between the IOL axis and the perpendicular visual axis
Any surgical complications and post-op complications will be documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None