Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Peking University Third Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- monocular and binocular visual acuity
- Last Updated
- 6 years ago
Overview
Brief Summary
This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.
Detailed Description
The subjects will undergo uneventful phacoemulsification and implantation of IOL. The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with unilateral or bilateral age related cataracts
- •Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter
Exclusion Criteria
- •Pregnant or nursing women
- •In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
- •Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- •History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
- •Patients with history of ocular trauma or prior ocular surgery including refractive procedures
- •postoperative visual acuity of worse than 0.2 logMAR in any eye
- •Patients using systemic or ocular medication that affect visual acuity.
- •Patients participating in other clinical trials during the study.
Outcomes
Primary Outcomes
monocular and binocular visual acuity
Time Frame: 3 months postoperatively
uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast
Secondary Outcomes
- Fusion function(3 months postoperatively)
- Binocular Contrast sensitivity(3 months postoperatively)
- Subjective visual quality(3 months postoperatively)
- Binocular Defocus Curve(3 months postoperatively)
- stereopsis(3 months postoperatively)