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

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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

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.

Condition or disease Intervention/treatment Phase
Cataract Presbyopia Device: TecnisSymfony® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: TecnisSymfony intraocular lens insertion group Device: TecnisSymfony®
Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501654


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Mee Kum Kim, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Mee Kum Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03501654     History of Changes
Other Study ID Numbers: TecnisSymfony Trial
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mee Kum Kim, Seoul National University Hospital:
Lenses, Intraocular
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors