Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Seoul National University Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change of visual acuity at near, intermediate and far
- Last Updated
- 8 years ago
Overview
Brief Summary
This is to evaluate the satisfaction of patient and physician about short-distance, medium-distance, long-distance postoperative vision and eyeglass dependence, glare, and visual acuity after insertion of the TECNIS® Symfony or TECNIS® Symfony Toric intraocular lens.
Detailed Description
The patients underwent uneventful phacoemulsification and implantation of TecnisSymfony®. Mean absolute error (MAE) at 1 month was compared in SRK/T, Holladay2, Haigis, Hoffer Q, Barrett Universal II, and Hill-RBF formula. At postoperative 1, 4, and 12 weeks, logMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm), and spherical equivalent (SE) in manifested refraction (MR) and automated refraction (AR) were measured. Wavefront aberration, contrast sensitivity test, and glare test were done at 12 weeks. The questionnaire was used to investigate glare, glasses dependency, and patient satisfaction at 12 weeks.
Investigators
Mee Kum Kim
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with unilateral or bilateral cataract
- •Sixteen years and older
- •Regular corneal topography and corneal astigmatism
- •Corneal astigmatism 0.75 Diopter and less for TECNIS® Symfony IOL, and between 1.0 and 3.62 Diopter for TECNIS® Symfony toric IOL
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, Malfan syndrome, etc.)
- •White cataract
- •Patients who need intraocular lens outside of range
- •In the presence of other ocular diseases that is expected to have a poor final visual acuity of less than 20/30 after surgery (amblyopia, strabismus, keratoconus, etc.)
- •Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- •Patients using systemic or ocular medication that affect visual acuity.
- •Patients who had previously undergone refractive surgery.
- •Patients participating in other clinical trials during the study.
Outcomes
Primary Outcomes
Change of visual acuity at near, intermediate and far
Time Frame: preoperative(last outpatient follow-up before the surgery), 1 month after surgery, 3 months after surgery.
LogMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm) were measured at preoperative (last outpatient follow-up before the surgery), postoperative 1, 4, and 12 weeks.
Secondary Outcomes
- Spectacle dependence evaluation by questionnaire(One month and three months after the surgery.)
- Photic phenomena evaluation by questionnaire.(One month and three months after the surgery.)