NCT06383754

Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Senile Cataract
• Epiretinal Membrane
• Vitreous Hemorrhage

Interventions

Type	Name	Description
DEVICE	Clareon	Monofocal intraocular lens
DEVICE	Tecnis 1	Monofocal 1 Piece intraocular lens

Timeline

• Start date: 2021-06-07
• Primary completion: 2024-03-08
• Completion: 2024-03-15
• First posted: 2024-04-25
• Last updated: 2024-04-25

Locations

1 site across 1 country: Hong Kong