Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

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.

Study Overview

• Status: Completed
• Conditions: Vitreous Hemorrhage; Epiretinal Membrane; Senile Cataract
• Intervention / Treatment: Device: Clareon; Device: Tecnis 1

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Grantham Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clareon IOL from Alcon; Monofocal artificial lens implanted in the eye following cataract surgery	Device: Clareon; Monofocal intraocular lens
Active Comparator: Tecnis 1 from from Precision Lens; Monofocal 1 piece IOL implanted in the eye following cataract surgery	Device: Tecnis 1; Monofocal 1 Piece intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Position stability of Clareon and Tecnis 1 IOL	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.	1 week, 1 month and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Nicholas Fung, The University of Hong Kong

Publications and helpful links

General Publications

• Lane S, Collins S, Das KK, Maass S, Thatthamla I, Schatz H, Van Noy S, Jain R. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019 Apr;45(4):501-506. doi: 10.1016/j.jcrs.2018.10.043. Epub 2019 Jan 25.
• Korynta J, Bok J, Cendelin J. Changes in refraction induced by change in intraocular lens position. J Refract Corneal Surg. 1994 Sep-Oct;10(5):556-64.
• Wang L, Koch DD. Effect of decentration of wavefront-corrected intraocular lenses on the higher-order aberrations of the eye. Arch Ophthalmol. 2005 Sep;123(9):1226-30. doi: 10.1001/archopht.123.9.1226.
• Rosales P, Marcos S. Phakometry and lens tilt and decentration using a custom-developed Purkinje imaging apparatus: validation and measurements. J Opt Soc Am A Opt Image Sci Vis. 2006 Mar;23(3):509-20. doi: 10.1364/josaa.23.000509.
• de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.
• Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.
• Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding against guessing. Lancet. 2002 Mar 16;359(9310):966-70. doi: 10.1016/S0140-6736(02)08029-7.
• Nagy ZZ, McAlinden C. Femtosecond laser cataract surgery. Eye Vis (Lond). 2015 Jun 30;2:11. doi: 10.1186/s40662-015-0021-7. eCollection 2015.
• Pan CW, Liu H, Sun HP, Xu Y. Increased Difficulties in Managing Stairs in Visually Impaired Older Adults: A Community-Based Survey. PLoS One. 2015 Nov 6;10(11):e0142516. doi: 10.1371/journal.pone.0142516. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Lens Diseases; Eye Hemorrhage; Hemorrhage; Cataract; Epiretinal Membrane; Vitreous Hemorrhage
• Other Study ID Numbers: Clove

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: By direct contact to the corresponding author or PI
• IPD Sharing Time Frame: 5 years after the study ends
• IPD Sharing Access Criteria: Case by case
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No