Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

NCT06383754 | Completed DMC

• 1 other identifier: Clove
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Senile Cataract; Epiretinal Membrane; Vitreous Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Visual acuity

  1 week, 1 month and 6 months

• Refraction

  1 week, 1 month and 6 months

• Axial movement

  1 week, 1 month and 6 months

• Decentration

  1 week, 1 month and 6 months

• Compare intra operative and post operative complication

  1 week, 1 month and 6 months

Study Arms (2)

Clareon IOL from Alcon

EXPERIMENTAL

Monofocal artificial lens implanted in the eye following cataract surgery

Device: Clareon

Tecnis 1 from from Precision Lens

ACTIVE COMPARATOR

Monofocal 1 piece IOL implanted in the eye following cataract surgery

Device: Tecnis 1

Interventions

Clareon DEVICE

Monofocal intraocular lens

Clareon IOL from Alcon

Tecnis 1 DEVICE

Monofocal 1 Piece intraocular lens

Tecnis 1 from from Precision Lens

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Grantham Hospital

Hong Kong, Hong Kong

Location

Related Publications (9)

• 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.

  PMID: 26605364 BACKGROUND

• 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.

  PMID: 7530106 BACKGROUND

• 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.

  PMID: 16157803 BACKGROUND

• 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.

  PMID: 16539046 BACKGROUND

• 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.

  PMID: 17321392 BACKGROUND

• Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.

  PMID: 25788077 BACKGROUND

• 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.

  PMID: 11918933 BACKGROUND

• 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.

  PMID: 26545238 BACKGROUND

• 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.

  PMID: 30686704 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane; Vitreous Hemorrhage

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Fung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are randomised and masked from the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Asst Professor

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 25, 2024
• Study Start: June 7, 2021
• Primary Completion: March 8, 2024
• Study Completion: March 15, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 5 years after the study ends
• Access Criteria: Case by case

Locations

HK (1)