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Completed

NCT Number: NCT06383754

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grantham Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clareon

Device

Monofocal intraocular lens

Tecnis 1

Device

Monofocal 1 Piece intraocular lens

Primary outcomes

  1. Position stability of Clareon and Tecnis 1 IOL

    Time frame: 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 outcomes

  1. Visual acuity

    Time frame: 1 week, 1 month and 6 months

    Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart

  2. Refraction

    Time frame: 1 week, 1 month and 6 months

    Refraction will be measured by an autorefractor, and the unit of measurement is Diopter.

  3. Axial movement

    Time frame: 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.

  4. Decentration

    Time frame: 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.

  5. Compare intra operative and post operative complication

    Time frame: 1 week, 1 month and 6 months

    Any surgical complications and post operative complications will be documented.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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