Cataract SenileNCT05129566
Evaluation of Axial Stability of Two Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm
A study testing IOL Clareon AutonoMe and IOL Hoya iSert 251 in people with Cataract Senile and Myopia, High-Grade, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
Trial summary
Some parameters, such as a change in the optic tilt and axial decentration, can affect the optical characteristics of intraocular lenses (IOLs) in postoperative period, which leads to residual refractive errors and other complications. Read more about this study
- Who is it for?
- Ages 50 to 78 years
- Conditions the study is for
- Cataract Senile, Myopia, High-Grade, Corneal Astigmatism
- What is being tested?
- IOL Clareon AutonoMe and IOL Hoya iSert 251
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2021to 20 Apr 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman 50 years and older with indicated cataract surgery.
- Signed informed consent, given by the participant or his/her legal representative.
- Ability to understand Russian spoken and written language.
- Sanitated oral cavity.
- Intraocular pressure in normal range.
- Axial eye length> 26 mm.
Show all 9Show fewer
- Corneal astigmatism <1.0 diopters.
- The presence of age-related cataract with high myopia and low visual acuity (less than 0.5 with correction), the cornea thickness in the central optical zone is not less than 500 microns and not more than 600 microns, and the density of endothelial cells is higher than 2300 cells / mm2.
- Patients who have passed the entire tests for hospitalization in hospital and also have received the admission (the conclusion) of the therapist for the surgery.
Who cannot join
- Inability to give signed informed consent.
- Age under 50 years.
- History of allergic reactions to antibiotics, glucocorticosteroids, medications for local and general anesthesia.
- Diagnosed neoplastic process or treatment for tumor disease.
- Positive tests for infectious: HIV, syphilis, Hepatitis B, Hepatitis C.
- Any medical, psychiatric and/or condition, including cachexia, or social conditions that the investigator believes would interfere with or contraindicate adherence to the research protocol or the ability to provide signed informed consent.
Show all 20Show fewer
- Active ophthalmic infection.
- Uncontrolled glaucoma
- Retinal defunctioning (no light perception and/or retinal detachment).
- Absence of the electric activity of the optic nerve and/or retina.
- Concomitant ocular pathology, such as the subluxation of the lens, glaucoma, pathology of the central retina, diabetic retinopathy, scars and opacities of the cornea, keratoconus, pathology of the corneal endothelium (Fuchs corneal dystrophy), pseudoexfoliative syndrome with pronounced impairment of the diaphragmatic function of the pupil, a non-functioning retina (lack of light perception and/or its detachment according to ultrasound examination), lack of electrical activity of the optic nerve and retina according to electrophysiological examination, etc.
- Patients with a serious general medical condition.
- Systemic use / administration of drugs that may affect the anatomical or functional characteristics of the cornea (amiodarone, β-blockers, tetracycline, etc.)
- Any pathology of the eye associated with myopia and myopic changes inside the eye (for example, myopic staphyloma) that may affect the results of the study.
- Regular intake of medications that may affect the proper function of the eye (antiglaucoma drugs, antibiotics, systemic immunosuppressive therapy, etc.)
- Systemic pathologies with possible damage to the cornea.
- Amblyopia.
- Any other concomitant ocular pathology, trauma or surgery in history.
- A patient who cannot adhere to the schedule of visits for research or treatment (for example, patients from other cities).
- Suspected drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Russia1 site
The S. N. Fyodorov Eye Microsurgery Federal State Institution
Moscow, 127486
About this study
Official title: Comparative Evaluation of Long-term Axial Stability of Two Different Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm
Some parameters, such as a change in the optic tilt and axial decentration, can affect the optical characteristics of intraocular lenses (IOLs) in postoperative period, which leads to residual refractive errors and other complications.
The stability of the intraocular lens in the eye is largely dependent on the mechanical design of its haptic support elements. Thus, the new Clareon IOL has a flat haptic with a flexible design that minimizes axial changes and allows the IOL to maintain a stable position in a given plane during compression.
Read more
Currently there is no published data of the stability for Clareon AutonoMe IOL for long eyes.
The purpose of the current study is to evaluate and compare the axis displacement and stability of optical tilt, visual and refractive results in patients after implantation of two different models of intraocular lenses: Clareon AutonoMe (Alcon, USA) and Hoya iSert 251 (Japan) in the long-term postoperative period (after cataract surgery).
Read the detailed description
The optical performance of intraocular lenses (IOLs) can be affected by changes in optic tilt and decentration that occur after implantation, resulting in residual refractive errors and other complications. Intraocular lens stability is largely dependent on the mechanical design of the haptics. Clareon IOL has a flat haptic with a flexible design that minimizes axial changes and allows the IOL to maintain a stable position in a given plane during compression.
Based on our knowledge, nobody has compared Clareon AutonoMe and Hoya iSert 251 IOLs in clinical setting.
Scientific Rationale:
This study investigates the stability of IOLs in patients with long axial length. IOL stability on long eyes has a limited clinical data, no in Vivo research has been done. It is known that eyes with long axial length have a large capsule bag. With such eyes, it is difficult to predict the effective lens position.
Each 0,5 mm axial displacement lead to approximately 0,5 D of the refractive error.
For long eyes, it is important to use the latest generation of multi-component IOL calculation formulas for accurately prediction of effective lens position.
The mail purpose of the study is to evaluate and compare the axis displacement and stability of optical tilt, visual and refractive results in patients after implantation of two different models of intraocular lenses: Clareon AutonoMe (Alcon, USA) and Hoya iSert 251 (Japan) in the long-term postoperative period (after cataract surgery).
The research purpose is to evaluate the prediction error for each IOL calculation formula (Barrett Universal II, Kane, EVO, Holladay I with Van Koch correction)
- Conditions
- Cataract Senile, Myopia, High-Grade, Corneal Astigmatism
- Being tested
- IOL Clareon AutonoMe, IOL Hoya iSert 251
- Keywords
- Axial stability, cataract surgery, IOL, high myopia
- Medical subject headings
- Myopia, Astigmatism, Intraocular Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL Clareon AutonoMeProcedure or surgery
Phacoemulsification of cataract with implantation of two types of IOLs - Clareon AutonoMe and Hoya iSert 251. Operations will be performed by one surgeon using the Centurion vision system under control of the Verion navigation system. The Verion system will be used for capsulorhexis and IOL centration (limbus centration).
IOL Hoya iSert 251Procedure or surgery
Phacoemulsification of cataract with implantation of two types of IOLs - Clareon AutonoMe and Hoya iSert 251. Operations will be performed by one surgeon using the Centurion vision system under control of the Verion navigation system. The Verion system will be used for capsulorhexis and IOL centration (limbus centration).
| Study group | Role | What they receive |
|---|---|---|
| IOL Clareon AutonoMe | Experimental | The first group of patients (39 eyes) who received the monofocal IOL Clareon AutonoMe after the phacoemulsification of cataract. Receives: Procedure: IOL Clareon AutonoMe |
| IOL Hoya iSert 251 | Active comparator | the second group of patients (39 eyes) who received the monofocal IOL Hoya iSert 251 after the phacoemulsification of cataract Receives: Procedure: IOL Hoya iSert 251 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular lens axial displacement
Axial displacement of the intraocular lens, stable position of the intraocular lens in the capsule bag after surgery, optics tilt, deviation from baseline, the distance from the corneal epithelium to the anterior surface of the intraocular lens, the stretching degree of the surgical wound will be assessed by the anterior segment OCT (AS-OCT).
Measured: 6 months
Secondary outcomes (4)
Near and distance vision visual acuity
Improving the clarity of images of observed objects. For one focus distance (reading and working at near / far (depending on the calculation of the IOL for emmetropia or weak myopic refraction) / intermediate distance, it is possible to use spectacle correction in the postoperative period.
Measured: 6 months
Patient's subjective satisfaction of with the quality of vision
Increased subjective satisfaction of patients with the quality of vision after surgery will be assessed using the VF-14 questionnaire (Steinberg E.P., 1994).
Measured: 6 months
Deviation from emmetropic refraction
Accurate IOL calculation before surgery.
Measured: 6 months
Number of intra- and postoperative complications
Intra- and postoperative complications in the operated eye will be assessed according to the observation data of the research subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2022
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies of the same condition, open and under way.
- 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
- Model description
- The first group of patients will receive the IOL Clareon AutonoMe (Alcon, USA), and the second group of patients will receive the IOL Hoya iSert 251 (Japan), 39 eyes in each group, total 78 patients, 78 eyes.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Boris Malyugin, The S.N. Fyodorov Eye Microsurgery State Institution
- Investigators
- Boris E Malyugin, MD, PhD, Principal investigator, The S. Fyodorov Eye Microsurgery Federal State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129566
- Sponsor's protocol ID
- #108.1_06092021
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share Clinical Study Report, present and publish results of the study.
Publications
Wirtitsch MG, Findl O, Menapace R, Kriechbaum K, Koeppl C, Buehl W, Drexler W. Effect of haptic design on change in axial lens position after cataract surgery. J Cataract Refract Surg. 2004 Jan;30(1):45-51. doi: 10.1016/S0886-3350(03)00459-0.
PubMed 14967267Remon L, Cabeza-Gil I, Calvo B, Poyales F, Garzon N. Biomechanical Stability of Three Intraocular Lenses With Different Haptic Designs: In Silico and In Vivo Evaluation. J Refract Surg. 2020 Sep 1;36(9):617-624. doi: 10.3928/1081597X-20200713-02.
PubMed 32901830Bang S, Edell E, Yu Q, Pratzer K, Stark W. Accuracy of intraocular lens calculations using the IOLMaster in eyes with long axial length and a comparison of various formulas. Ophthalmology. 2011 Mar;118(3):503-6. doi: 10.1016/j.ophtha.2010.07.008. Epub 2010 Sep 29.
PubMed 20884057Lane 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Long-term Axial Stability of Two Different Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm
- ClinicalTrials.gov ID
- NCT05129566
- Acronym / sponsor ID
- #108.1_06092021
- Conditions
- Cataract Senile, Myopia, High-Grade, Corneal Astigmatism
- Keywords
- Axial stability, cataract surgery, IOL, high myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Collaborators
- Alcon Research
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 22 Nov 2021 (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.
Some parameters, such as a change in the optic tilt and axial decentration, can affect the optical characteristics of intraocular lenses (IOLs) in postoperative period, which leads to residual refractive errors and other complications.
The stability of the intraocular lens in the eye is largely dependent on the mechanical design of its haptic support elements. Thus, the new Clareon IOL has a flat haptic with a flexible design that minimizes axial changes and allows the IOL to maintain a stable position in a given plane during compression.
Currently there is no published data of the stability for Clareon AutonoMe IOL for long eyes.
The purpose of the current study is to evaluate and compare the axis displacement and stability of optical tilt, visual and refractive results in patients after implantation of two different models of intraocular lenses: Clareon AutonoMe (Alcon, USA) and Hoya iSert 251 (Japan) in the long-term postoperative period (after cataract surgery).
Detailed description
The optical performance of intraocular lenses (IOLs) can be affected by changes in optic tilt and decentration that occur after implantation, resulting in residual refractive errors and other complications. Intraocular lens stability is largely dependent on the mechanical design of the haptics. Clareon IOL has a flat haptic with a flexible design that minimizes axial changes and allows the IOL to maintain a stable position in a given plane during compression.
Based on our knowledge, nobody has compared Clareon AutonoMe and Hoya iSert 251 IOLs in clinical setting.
Scientific Rationale:
This study investigates the stability of IOLs in patients with long axial length. IOL stability on long eyes has a limited clinical data, no in Vivo research has been done. It is known that eyes with long axial length have a large capsule bag. With such eyes, it is difficult to predict the effective lens position.
Each 0,5 mm axial displacement lead to approximately 0,5 D of the refractive error.
For long eyes, it is important to use the latest generation of multi-component IOL calculation formulas for accurately prediction of effective lens position.
The mail purpose of the study is to evaluate and compare the axis displacement and stability of optical tilt, visual and refractive results in patients after implantation of two different models of intraocular lenses: Clareon AutonoMe (Alcon, USA) and Hoya iSert 251 (Japan) in the long-term postoperative period (after cataract surgery).
The research purpose is to evaluate the prediction error for each IOL calculation formula (Barrett Universal II, Kane, EVO, Holladay I with Van Koch correction)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group of patients will receive the IOL Clareon AutonoMe (Alcon, USA), and the second group of patients will receive the IOL Hoya iSert 251 (Japan), 39 eyes in each group, total 78 patients, 78 eyes.
| Arm | Type | Receives |
|---|---|---|
| IOL Clareon AutonoMe | Experimental | Procedure: IOL Clareon AutonoMeThe first group of patients (39 eyes) who received the monofocal IOL Clareon AutonoMe after the phacoemulsification of cataract. |
| IOL Hoya iSert 251 | Active comparator | Procedure: IOL Hoya iSert 251the second group of patients (39 eyes) who received the monofocal IOL Hoya iSert 251 after the phacoemulsification of cataract |
Who may qualify
- Ages
- 50 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Man or woman 50 years and older with indicated cataract surgery.
- Signed informed consent, given by the participant or his/her legal representative.
- Ability to understand Russian spoken and written language.
- Sanitated oral cavity.
- Intraocular pressure in normal range.
Key exclusion criteria (20 listed)
- Inability to give signed informed consent.
- Age under 50 years.
- History of allergic reactions to antibiotics, glucocorticosteroids, medications for local and general anesthesia.
- Diagnosed neoplastic process or treatment for tumor disease.
- Positive tests for infectious: HIV, syphilis, Hepatitis B, Hepatitis C.
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 |
|---|---|---|
| IOL Clareon AutonoMePhacoemulsification of cataract with implantation of two types of IOLs - Clareon AutonoMe and Hoya iSert 251. Operations will be performed by one surgeon using the Centurion vision system under control of the Verion navigation system. The Verion system will be used for capsulorhexis and IOL centration (limbus centration). | Procedure or surgery | IOL Clareon AutonoMe |
| IOL Hoya iSert 251Phacoemulsification of cataract with implantation of two types of IOLs - Clareon AutonoMe and Hoya iSert 251. Operations will be performed by one surgeon using the Centurion vision system under control of the Verion navigation system. The Verion system will be used for capsulorhexis and IOL centration (limbus centration). | Procedure or surgery | IOL Hoya iSert 251 |
Primary outcome
Intraocular lens axial displacement
Time frame: 6 months
Axial displacement of the intraocular lens, stable position of the intraocular lens in the capsule bag after surgery, optics tilt, deviation from baseline, the distance from the corneal epithelium to the anterior surface of the intraocular lens, the stretching degree of the surgical wound will be assessed by the anterior segment OCT (AS-OCT).
4 secondary outcomes
Near and distance vision visual acuity
Time frame: 6 months
Patient's subjective satisfaction of with the quality of vision
Time frame: 6 months
Deviation from emmetropic refraction
Time frame: 6 months
Number of intra- and postoperative complications
Time frame: 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 23 Apr 2024.
- Background: PubMed 14967267Wirtitsch MG, Findl O, Menapace R, Kriechbaum K, Koeppl C, Buehl W, Drexler W. Effect of haptic design on change in axial lens position after cataract surgery. J Cataract Refract Surg. 2004 Jan;30(1):45-51. doi: 10.1016/S0886-3350(03)00459-0.
- Background: PubMed 32901830Remon L, Cabeza-Gil I, Calvo B, Poyales F, Garzon N. Biomechanical Stability of Three Intraocular Lenses With Different Haptic Designs: In Silico and In Vivo Evaluation. J Refract Surg. 2020 Sep 1;36(9):617-624. doi: 10.3928/1081597X-20200713-02.
- Background: PubMed 20884057Bang S, Edell E, Yu Q, Pratzer K, Stark W. Accuracy of intraocular lens calculations using the IOLMaster in eyes with long axial length and a comparison of various formulas. Ophthalmology. 2011 Mar;118(3):503-6. doi: 10.1016/j.ophtha.2010.07.008. Epub 2010 Sep 29.
- 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. We plan to share Clinical Study Report, present and publish results of the study.
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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.
Boris E Malyugin, MD, PhD principal investigator
The S. Fyodorov Eye Microsurgery Federal State Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL Clareon AutonoMe and IOL Hoya iSert 251 in people with Cataract Senile and Myopia, High-Grade, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
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 9 inclusion and 20 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 23 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 Russia. 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?
Intraocular lens axial displacement (time frame: 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 NCT05129566, which also lists 4 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 23 Apr 2024.