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

Primary Purpose

Cataract, Presbyopia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TecnisSymfony®
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Lenses, Intraocular

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TecnisSymfony intraocular lens insertion group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Photic phenomena evaluation by questionnaire.
Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe).
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.

Full Information

First Posted
March 14, 2018
Last Updated
April 16, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03501654
Brief Title
Prospective Clinical Trial of Unilateral or Bilateral Implantation of TecnisSymfony IOL in Cataract Patients With Presbyopia
Official Title
Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia
Keywords
Lenses, Intraocular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TecnisSymfony intraocular lens insertion group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TecnisSymfony®
Intervention Description
Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).
Primary Outcome Measure Information:
Title
Change of visual acuity at near, intermediate and far
Description
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 Outcome Measure Information:
Title
Photic phenomena evaluation by questionnaire.
Description
Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe).
Time Frame
One month and three months after the surgery.
Title
Spectacle dependence evaluation by questionnaire
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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