Myopia
Conditions
Interventions
Experimental group:Posterior Chamber Phakic Intraocular Lens Implantation
Sponsors
Eye & 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, all genders. 2.IOL power range suitable for both eyes, as determined by a physician, between -3.25 D and -18.00 D (inclusive). 3.Preoperative best-corrected distance visual acuity of the eye scheduled for surgery > decimal 0.5. 4.Stable refractive error in the eye scheduled for surgery (change in spherical equivalent = ±0.75 D within the past year), verified by a continuous series of refractions/medical records/prescriptions/investigator inquiry covering at least 12 months prior to surgery. 5.Contact lens wearers must discontinue use prior to the initial preoperative refraction: rigid gas permeable or toric soft lenses for at least 2 weeks, and non-toric soft lenses for at least 3 days. 6.Ability to complete at least 12 months of follow-up visits; 7.Ability to understand the purpose of the trial, voluntarily participate, and provide personally signed informed consent;
Exclusion criteria
Exclusion criteria: 1.History of intraocular or corneal surgery in the eye scheduled for surgery. 2.Presence of systemic or ocular conditions that, in the investigator's judgment, may increase surgical risk, confound study results, or lead to complications, thereby making the subject unsuitable for surgery. 3.Use of systemic medications that, in the investigator's judgment, may confound study results or increase subject risk, thereby making the subject unsuitable for surgery. 4.Corneal endothelial cell density < 2000 cells/mm², or presence of keratoconus, corneal endothelial dystrophy, corneal edema, or other corneal pathologies in the eye scheduled for surgery. 5.Pregnancy or lactation at the time of screening. 6.Subjects with only one functional eye (monocular), or those with severe amblyopia or blindness in either eye. 7.Anterior chamber depth (distance from the corneal posterior surface to the anterior lens surface) < 2.50 mm in the eye scheduled for surgery. 8.Narrow anterior chamber angle in the eye scheduled for surgery (diagnosed as lower than Grade III or less than 20° by the Shaffer grading system). 9.Any other condition deemed by the investigator to make the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complication;Visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fundus examination;Anterior chamber depth;Intraocular pressure;Pupil diameter;IOL position;Anterior chamber angle;Objective Visual Quality;Keratometry;Central corneal thickness;Contrast sensitivity;Corneal endothelium;IOL haptic status;Refraction;Vault; | — |
Countries
China
Contacts
Public ContactWang Xiaoying
Eye & ENT hospital of Fudan University
Outcome results
None listed