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

Not Applicable

• Conditions: Cataract; Presbyopia
• Interventions: Device: TecnisSymfony®

• Registration Number: NCT03501654
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2018-03-14
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Primary Completion: 2018-05
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TecnisSymfony intraocular lens insertion group	TecnisSymfony®	-

Primary Outcome Measures

Name	Time	Method
Change of visual acuity at near, intermediate and far	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

Name	Time	Method
Spectacle dependence evaluation by questionnaire	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.
Photic phenomena evaluation by questionnaire.	One month and three months after the surgery.	Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe).

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of