Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

NCT ID: NCT06383754

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2024-03-15

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.

Conditions

Senile Cataract; Epiretinal Membrane; Vitreous Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clareon IOL from Alcon

Monofocal artificial lens implanted in the eye following cataract surgery

Group Type: EXPERIMENTAL

Clareon

Intervention Type: DEVICE

Monofocal intraocular lens

Tecnis 1 from from Precision Lens

Monofocal 1 piece IOL implanted in the eye following cataract surgery

Group Type: ACTIVE_COMPARATOR

Tecnis 1

Intervention Type: DEVICE

Monofocal 1 Piece intraocular lens

Interventions

Clareon

Monofocal intraocular lens

Intervention Type: DEVICE

Tecnis 1

Monofocal 1 Piece intraocular lens

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nicholas Fung

Clinical Asst Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Fung

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Grantham Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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Other Identifiers

Clove

Identifier Type: -

Identifier Source: org_study_id