CompletedNCT06383754Updated Apr 25, 2024

Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

An interventional study of Clareon and Tecnis 1 in Senile Cataract, Epiretinal Membrane and Vitreous Hemorrhage, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 2 years 9 months after the study started (first participant enrolled Jun 2021, registered Mar 2024).

Phase: Not applicable
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 50 Years to 80 Years
Sex: All

Study 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.

Read the 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 studied

Senile Cataract
Epiretinal Membrane
Vitreous Hemorrhage

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In context

Epiretinal Membrane

123 studies on the registry are indexed under Epiretinal Membrane; 15 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 75 interventional studies indexed under Epiretinal Membrane.

Browse Epiretinal Membrane studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse The University of Hong Kong studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 50 participants (actual)

Study arms

Experimental
Clareon IOL from Alcon
Monofocal artificial lens implanted in the eye following cataract surgery
Device: Clareon
Active comparator
Tecnis 1 from from Precision Lens
Monofocal 1 piece IOL implanted in the eye following cataract surgery
Device: Tecnis 1

Interventions

DeviceClareon
Monofocal intraocular lens
DeviceTecnis 1
Monofocal 1 Piece intraocular lens

What researchers measure

Primary outcomes

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.
Time frame: 1 week, 1 month and 6 months

Secondary outcomes

Visual acuity
Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame: 1 week, 1 month and 6 months
Refraction
Refraction will be measured by an autorefractor, and the unit of measurement is Diopter.
Time frame: 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.
Time frame: 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.
Time frame: 1 week, 1 month and 6 months
Compare intra operative and post operative complication
Any surgical complications and post operative complications will be documented.
Time frame: 1 week, 1 month and 6 months

Study locations

1 site

Grantham Hospital
Hong Kong, Hong Kong

References and documents

Publications

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. PubMed 26605364 ↗
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. PubMed 7530106 ↗
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. PubMed 16157803 ↗
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. PubMed 16539046 ↗
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. PubMed 17321392 ↗
Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available. PubMed 25788077 ↗
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. PubMed 11918933 ↗
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. PubMed 26545238 ↗
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. PubMed 30686704 ↗

Individual participant data

Plan to share: Yes — By direct contact to the corresponding author or PI

Supporting information: Study protocol, Clinical study report

Time frame: 5 years after the study ends

Access criteria: Case by case

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Mar 2024, 33 months.

Of 31 interventional studies with no phase under Epiretinal Membrane, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 60. This study's 33 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 20, 2024
First posted: Apr 25, 2024
StartActual: Jun 7, 2021
Primary completionActual: Mar 8, 2024
CompletionActual: Mar 15, 2024
Last update: Apr 25, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06383754
Lead sponsor: The University of Hong Kong
Responsible party: Dr. Nicholas Fung (Clinical Asst Professor, The University of Hong Kong) — Principal investigator
First posted: Apr 25, 2024
Start date: Jun 7, 2021
Primary completion: Mar 8, 2024
Completion: Mar 15, 2024
Last update: Apr 25, 2024

Study contacts

Nicholas Fung

principal investigator · The University of Hong Kong

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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