Prospective Clinical Trial of Unilateral or Bilateral Implantation of TecnisSymfony IOL in Cataract Patients With Presbyopia

Seoul National University Hospital20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract Presbyopia

Interventions

TecnisSymfony®DEVICE

Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change of visual acuity at near, intermediate and far

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.

Time frame: preoperative(last outpatient follow-up before the surgery), 1 month after surgery, 3 months after surgery.

Secondary Outcomes

Photic phenomena evaluation by questionnaire.

Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe).

Time frame: One month and three months after the surgery.

Spectacle dependence evaluation by questionnaire

Patients were asked for 0, 25, 50, 75, and 100% of the need to wear glasses at distance, mid-range, and near distance.

Time frame: One month and three months after the surgery.

Data from ClinicalTrials.gov

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