Refractive error
Conditions
Interventions
Test Group:implant MPL
Control group:implant ICL
exploratory trial:implant MPL
Sponsors
EYE & ENT HOSPITAL OF FUDAN UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Part I Subjects were required to meet all of the following criteria to be enrolled in the trial: 1.Subjects >=21 years of age, regardless of gender; 2.Patients with myopia ranging from -3.0 D to -18.0 D (including -3.0 D and -18.0 D); 3.Stable diopter in the last year, i.e. the diopter change =5.0 (corresponding to Snellen visual acuity of 20/20); 7.The anterior chamber depth is >=2.8 mm (measured from the corneal endothelium to the anterior vertex of the lens), and the chamber angle is open; 8.Corneal endothelial cell count >=2000/mm2, normal corneal morphology; 9.Subjects who, in the judgment of the investigator, are to undergo phakic posterior chamber IOL implantation for refractive correction; 10.The subject was able to understand the purpose of the trial, voluntarily participated in the trial, and was willing to sign written informed consent. Part II Subjects were required to meet all of the following criteria to be enrolled in the trial: 1.Subject’s age and myopia degree meet any of the following criteria: a.The subjects were 18-21 years old (including 18 years old, excluding 21 years old) and of any gender; Those with binocular myopia ranging from -3.0 D to -27.0 D (including -3.0 D and -27.0 D); b.Subjects >=21 years of age, regardless of gender; binocular myopia in the range of -18.0 D to -27.0 D (excluding -18.0 D, including -27.0 D); 2.Stable diopter in the last year, i.e. the diopter change =4.5 (corresponding to Snellen visual acuity of 20/67); 6.The anterior chamber depth is >=2.5 mm (measured from the corneal endothelium to the anterior vertex of the lens), and the chamber angle is open; 7.Corneal endothelial cell count >=2000/mm2, normal corneal morphology; 8.Subjects who, in the judgment of the investigator, are to undergo phakic posterior chamber IOL implantation for refractive correction; 9.The subject was able to understand the purpose of the trial, voluntarily participated in the trial, and was willing to sign written informed consent.
Exclusion criteria
Exclusion criteria: 1.fragile zonules, such as lens tremor, Marfan syndrome, Weill-Marchesani Syndrome, pseudoexfoliation syndrome; 2.History of intraocular or corneal surgery (including any type of surgery for refractive or therapeutic purposes), or previous ocular trauma; 3.Patients with active ocular lesions or infections; 4.Patients with chronic drug-induced miosis, cataract, lens morphology and position abnormality, glaucoma, diabetic retinopathy, retinal detachment, maculopathy, uveitis or iritis, etc., who are judged by the investigator to be unsuitable for phakic posterior chamber intraocular lens implantation; 5.Severe dry eye; 6.Abnormal intraocular pressure (normal intraocular pressure ranges from 10 to 21 mmHg, and the difference between two eyes should be less than 5 mmHg); 7.Keratoconus or other corneal distensibility changes in unstable state; 8.Severe adnexal lesions, such as eyelid defect and deformation, severe eyelid closure insufficiency, etc.; 9.Acute or chronic diseases such as chronic systemic diseases, autoimmune diseases, connective tissue diseases, or clinically significant atopic diseases, which may increase the risk to the subjects or confound the evaluation indexes of the trial according to the judgment of the investigator; 10.Taking systemic drugs that may inhibit wound healing within 3 months, such as glucocorticosteroids or antimetabolites; 11.Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the clinical trial; 12.Have worn soft contact lenses within 1 week, or worn hard oxygen permeable contact lenses within 3 weeks, or worn orthokeratology lenses within 3 months; 13.Have participated in or are participating in a drug clinical trial within 3 months, or have participated in or are participating in other medical device clinical trials within 30 days; 14.Other circumstances that, in the judgment of the investigator, are not suitable for enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product effectiveness at 180 +/-15 days after surgery;The effectiveness index at 180 days +/-15 days post-operation; | — |
Countries
China
Contacts
Public Contactzhouxingtao
EYE & ENT HOSPITAL OF FUDAN UNIVERSITY
Outcome results
None listed