Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

Not Applicable

Completed

• Conditions: Epiretinal Membrane; Vitreous Hemorrhage; Senile Cataract
• Interventions: Device: Clareon; Device: Tecnis 1

• Registration Number: NCT06383754
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2021-06-07
• Status Verified: 2024-03
• Primary Completion: 2024-03-08
• Study Completion: 2024-03-15
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage
• Age between 50 and 80 years.

Exclusion Criteria

• Diagnosis of vision-impairing diseases including uveitis, glaucoma and corneal pathologies resulting in high astigmatism, severe refractive error (preoperative spherical equivalent of either eye >-6.00D or +5.00D);
• Diagnosis of possible lenses instability including History of ocular trauma, Pseudoexfoliation syndrome; past refractive surgery or other ophthalmic surgery;
• Known Capsular or zonular disorders that might affect the post-operative centration of IOLs, e.g., pseudo-exfoliation syndrome or Marfan syndrome;
• Surgical complications including severe hyphema, iris injury, repeated IOL implantation during surgery, failure to achieve in-the-bag IOL implantation, posterior capsular rupture, usage of tamponade (gas or oil) and corneal sutures.
• Difficulty in obtaining IOL measurements (eg. Small pupil, corneal opacities, patient cooperation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clareon IOL from Alcon	Clareon	Monofocal artificial lens implanted in the eye following cataract surgery
Tecnis 1 from from Precision Lens	Tecnis 1	Monofocal 1 piece IOL implanted in the eye following cataract surgery

Primary Outcome Measures

Name	Time	Method
Position stability of Clareon and Tecnis 1 IOL	1 week, 1 month and 6 months	Two arms will compare Intraocular lens stability, which will be measured by it's tilt, measures in degrees from iris plane (0, deg). Tilt will be measured using Pentacam by Sasaki method.

Secondary Outcome Measures

Name	Time	Method
Axial movement	1 week, 1 month and 6 months	Axial movement will be measured by Pentacam (OCULUS Optikgeräte GmbH, Germany) using the Sasaki method. For axial movement unit of measurement is millimeter.
Decentration	1 week, 1 month and 6 months	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. The unit of measurement for decentration is millimeter.
Refraction	1 week, 1 month and 6 months	Refraction will be measured by an autorefractor, and the unit of measurement is Diopter.
Compare intra operative and post operative complication	1 week, 1 month and 6 months	Any surgical complications and post operative complications will be documented.
Visual acuity	1 week, 1 month and 6 months	Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart

Trial Locations

Locations (1)

Grantham Hospital; 🇭🇰 Hong Kong, Hong Kong