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

NCT03501654 | Unknown FDA Device

• 1 other identifier: TecnisSymfony Trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia

Keywords

Lenses, Intraocular

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Photic phenomena evaluation by questionnaire.

  One month and three months after the surgery.

• Spectacle dependence evaluation by questionnaire

  One month and three months after the surgery.

Study Arms (1)

TecnisSymfony intraocular lens insertion group

EXPERIMENTAL

Device: TecnisSymfony®

Interventions

TecnisSymfony® DEVICE

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

TecnisSymfony intraocular lens insertion group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Mee Kum Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 18, 2018
• Study Start: February 17, 2017
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)