Clinical trial · Interventional
Evaluation of Axial Stability of Two Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm
Comparative Evaluation of Long-term Axial Stability of Two Different Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cataract Senile | — | UNRESOLVED | — |
| Corneal Astigmatism | — | UNRESOLVED | — |
| Myopia, High-Grade | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IOL Clareon AutonoMe | Procedure | — | UNRESOLVED |
| IOL Hoya iSert 251 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IOL Clareon AutonoMe
- description
- The first group of patients (39 eyes) who received the monofocal IOL Clareon AutonoMe after the phacoemulsification of cataract.
- interventionNames
- Procedure: IOL Clareon AutonoMe
- type
- ACTIVE_COMPARATOR
- label
- IOL Hoya iSert 251
- description
- the second group of patients (39 eyes) who received the monofocal IOL Hoya iSert 251 after the phacoemulsification of cataract
- interventionNames
- Procedure: IOL Hoya iSert 251
Primary outcomes (1)
- measure
- Intraocular lens axial displacement
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
References
Publications (4)
- BACKGROUNDWirtitsch 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. PMID 14967267
- BACKGROUNDRemon 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. PMID 32901830
- BACKGROUNDBang 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. PMID 20884057
- BACKGROUNDLane 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