correcting/reducing myopia of -0.25D to -18.00D combined with astigmatism of +6.00D or less in adults
Conditions
Interventions
Experimental Group:The enrolled eyes were implanted with astigmatism correction intraocular lenses
Control group:Central foramen posterior chamber astigmatic refractive intraocular lenses were implanted in the enrolled eyes
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
21 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Age: 21 to 45 years old, gender not limited. 2. At least one eye has myopia ranging from -0.25D to -18.00D (including -0.25D and -18.00D) and astigmatism ranging from +0.25D to +6.00D (including +0.25D and +6.00D). 3. Be capable of completing at least six months of follow-up. 4. Those who can understand the purpose of the trial, voluntarily participate and have the informed consent form signed by the subjects themselves.
Exclusion criteria
Exclusion criteria: 1. Those who need to retain the degree of the intended surgical eye; 2. Patients whose best corrected distant visual acuity of the intended eye is less than 0.5 decimal visual acuity; 3. Patients with unstable refractive status of the intended eye (with a change in spherical or cylindrical equivalent refractive power of more than 0.5D within one year); 4. Patients whose pupils are less than 5.5mm after dilation of the intended eye and are insufficient to display the axial marking of the intraocular lens; 5. Those whose anterior chamber depth (the distance from the posterior surface of the cornea to the anterior surface of the lens) is less than 2.50 mm; 6. Those with a narrow anterior chamber Angle (diagnosed as below grade III or less than 20° by the Shaffer classification method); 7. The corneal endothelial cell density of the intended surgical eye is less than 2200/mm ²; 8. The intended surgical eye has irregular astigmatism, keratoconus, or other corneal lesions such as corneal endothelial dystrophy and corneal edema; 9. Patients with abnormal intraocular pressure (normal intraocular pressure range: 10 to 21 mmHg, and the difference in intraocular pressure between both eyes should be less than 5 mmHg); 10. As determined by researchers, those with severe dry eye syndrome; 11. Those with abnormal sagittal height of the natural lens as determined by researchers; 12. Those whose intended eye has a history of ocular trauma or intraocular surgery in the past; 13. Subjects with one eye or those with severe amblyopia or blindness in either eye; 14. Patients with acute, chronic or systemic non-ophthalmic diseases or conditions, or systemic connective tissue diseases or autoimmune diseases that may hinder the completion of the study, such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc. 15. Those with other ocular diseases, such as abnormal lenses, cataracts, glaucoma, diabetic retinopathy, retinal detachment, retinopathy (non-myopic fundus degenerative disease), iritis, uveitis, pigment diffusion syndrome, endophthalmitis, macular edema, macular degeneration, etc., as well as other serious ocular diseases or progressive diseases that threaten vision accompanying them; 16. Those with fragile or injured suspensory ligaments, such as those suffering from pseudo-exfoliation syndrome, Marfan syndrome or crystal fibrillation, etc. 17. Those who are pregnant, breastfeeding or planning to become pregnant during the follow-up period at the time of screening; 18. Patients who have stopped wearing soft contact lenses for less than 2 weeks and hard contact lenses for less than 1 month; 19. Those who have used drugs that affect vision (such as chlorpromazine, ethambutol, digitalis, chloroquine, etc.) within the three months prior to screening; 20. Those who have participated in clinical trials of other drugs or medical devices within three months prior to screening; 21. Patients with severe or unstable heart, liver, lung, kidney, endocrine (including thyroid dysfunction), blood, and psychiatric disorders; 22. Patients with contraindications for surgery indicated by electrocardiogram or laboratory test results; 23. Patients who have high visual expectations, or are overly sensitive, nervous, depressed, or picky after surgery; 24. Other situations that the researcher deems unsuitable for inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Refractive error at 1 week, 1 month, 3 months, and 6 months postoperatively, including cylindrical and spherical diopters;;Postoperative uncorrected far and near visual acuity at 1-2 days, 1 week, 1 month, 3 months, and 6 months; The best corrected far vision at 1 week, 1 month, 3 months, and 6 months after surgery; Near visual acuity under distance correction 6 months after surgery;;Stability of intraocular lens rotation at 1-2 days, 1 week, 1 month, 3 months, and 6 months after surgery;Subjective visual symptoms at 1 and 6 months after surgery; | — |
Primary
| Measure | Time frame |
|---|---|
| The percentage of cases with uncorrected far visual acuity of 0.5 or better at 6 months after surgery.; | — |
Countries
China
Contacts
Public ContactXingtao Zhou, Xiaoying Wang
Eye and ENT Hospital of Fudan University
Outcome results
None listed