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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03501654
Other study ID # TecnisSymfony Trial
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 14, 2018
Last updated April 16, 2018
Start date February 17, 2017
Est. completion date December 2018

Study information

Verified date April 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Photic phenomena evaluation by questionnaire. Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe). One month and three months after the surgery.
Secondary 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. One month and three months after the surgery.
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