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

NCT ID: NCT03501654

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2018-12-31

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.

Conditions

Cataract; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TecnisSymfony intraocular lens insertion group

Group Type: EXPERIMENTAL

TecnisSymfony®

Intervention Type: DEVICE

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

Interventions

TecnisSymfony®

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mee Kum Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mee Kum Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

TecnisSymfony Trial

Identifier Type: -

Identifier Source: org_study_id