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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501654
Recruitment Status : Active, not recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mee Kum Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date April 18, 2018
Actual Study Start Date  ICMJE February 17, 2017
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
  • Photic phenomena evaluation by questionnaire. [ Time Frame: One month and three months after the surgery. ]
    Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe).
  • Spectacle dependence evaluation by questionnaire [ Time Frame: One month and three months after the surgery. ]
    Patients were asked for 0, 25, 50, 75, and 100% of the need to wear glasses at distance, mid-range, and near distance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Clinical Trial of Unilateral or Bilateral Implantation of TecnisSymfony IOL in Cataract Patients With Presbyopia
Official Title  ICMJE Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Presbyopia
Intervention  ICMJE Device: TecnisSymfony®
Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).
Study Arms  ICMJE Experimental: TecnisSymfony intraocular lens insertion group
Intervention: Device: TecnisSymfony®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 16, 2018)
20
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03501654
Other Study ID Numbers  ICMJE TecnisSymfony Trial
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mee Kum Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mee Kum Kim, M.D., Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP