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

Cataract Clinical Trial

Official title:

Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03501654
• Other study ID #: TecnisSymfony Trial
• 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
• 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.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

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.