Senile CataractNCT06383754
Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study
A study testing Clareon and Tecnis 1 in people with Senile Cataract and Epiretinal Membrane, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Senile Cataract, Epiretinal Membrane, Vitreous Hemorrhage
- What is being tested?
- Clareon and Tecnis 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Jun 2021to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage
- Age between 50 and 80 years.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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.
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
- Senile Cataract, Epiretinal Membrane, Vitreous Hemorrhage
- Being tested
- Clareon, Tecnis 1
- Medical subject headings
- Epiretinal Membrane, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClareonDevice
Monofocal intraocular lens
Tecnis 1Device
Monofocal 1 Piece intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Clareon IOL from Alcon | Experimental | Monofocal artificial lens implanted in the eye following cataract surgery Receives: Device: Clareon |
| Tecnis 1 from from Precision Lens | Active comparator | Monofocal 1 piece IOL implanted in the eye following cataract surgery Receives: Device: Tecnis 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week, 1 month and 6 months
Secondary outcomes (5)
Visual acuity
Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Measured: 1 week, 1 month and 6 months
Refraction
Refraction will be measured by an autorefractor, and the unit of measurement is Diopter.
Measured: 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.
Measured: 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.
Measured: 1 week, 1 month and 6 months
Compare intra operative and post operative complication
Any surgical complications and post operative complications will be documented.
Measured: 1 week, 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start7 Jun 2021
- Primary completion8 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Senile CataractStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nicholas Fung, The University of Hong Kong
- Investigators
- Nicholas Fung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383754
- Sponsor's protocol ID
- Clove
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By direct contact to the corresponding author or PI
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 26605364Korynta 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 7530106Wang 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 16157803Rosales 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 16539046de 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 17321392Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.
PubMed 25788077Schulz 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 11918933Pan 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 26545238Lane 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study
- ClinicalTrials.gov ID
- NCT06383754
- Acronym / sponsor ID
- Clove
- Conditions
- Senile Cataract, Epiretinal Membrane, Vitreous Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon IOL from Alcon | Experimental | Device: ClareonMonofocal artificial lens implanted in the eye following cataract surgery |
| Tecnis 1 from from Precision Lens | Active comparator | Device: Tecnis 1Monofocal 1 piece IOL implanted in the eye following cataract surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage
- Age between 50 and 80 years.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClareonMonofocal intraocular lens | Device | Clareon IOL from Alcon |
| Tecnis 1Monofocal 1 Piece intraocular lens | Device | Tecnis 1 from from Precision Lens |
Primary outcome
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.
5 secondary outcomes
Visual acuity
Time frame: 1 week, 1 month and 6 months
Refraction
Time frame: 1 week, 1 month and 6 months
Axial movement
Time frame: 1 week, 1 month and 6 months
Decentration
Time frame: 1 week, 1 month and 6 months
Compare intra operative and post operative complication
Time frame: 1 week, 1 month and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 26605364Nagy ZZ, McAlinden C. Femtosecond laser cataract surgery. Eye Vis (Lond). 2015 Jun 30;2:11. doi: 10.1186/s40662-015-0021-7. eCollection 2015.
- Background: PubMed 7530106Korynta 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.
- Background: PubMed 16157803Wang 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.
- Background: PubMed 16539046Rosales 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.
- Background: PubMed 17321392de 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.
- Background: PubMed 25788077Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.
- Background: PubMed 11918933Schulz 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.
- Background: PubMed 26545238Pan 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.
- Background: PubMed 30686704Lane 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.
- Individual participant dataSharing planned: Yes. By direct contact to the corresponding author or PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Fung principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon and Tecnis 1 in people with Senile Cataract and Epiretinal Membrane, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position stability of Clareon and Tecnis 1 IOL (time frame: 1 week, 1 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06383754, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.