Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial

NCT06658119 | Recruiting

• 1 other identifier: 20241068
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.

Conditions

Cataract

Keywords

cataract surgery; intraocular lens; extended depth-of-focus

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Visual acuity will be assessed using the Standard Logarithmic Visual Acuity Chart. The results will be recorded in decimal and converted to logMAR and Snellen equivalent.

  1 day, 1 week, 1 month, 3 months postoperatively

Secondary Outcomes (3)

• Visual quality

  3 months postoperatively

• defocus curve

  3 months postoperatively

• contrast sensitivity

  3 months postoperatively

Study Arms (2)

Tecnis Synergy ZFR00 IOL

EXPERIMENTAL

Tecnis Synergy ZFR00 IOL will be implanted in the patient's eye during cataract surgery.

Procedure: cataract surgery

Tecnis Symfony ZXR00 IOL

PLACEBO COMPARATOR

Tecnis Symfony ZXR00 IOL will be implanted in the patient's eye during cataract surgery.

Procedure: cataract surgery

Interventions

cataract surgery PROCEDURE

The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00).

Also known as: intraocular lens implantation

Tecnis Synergy ZFR00 IOL

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age-related cataract patients aged between 40 to 80
• patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
• patients who plan to receive femtosecond laser-assisted cataract surgery

You may not qualify if:

• patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
• patients with history of ocular trauma or surgery
• patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
• patients with concurrent severe systemic diseases
• patients who lack of cooperation

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310058, China

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Yueyang Zhong, MD.

CONTACT

+8618868125901; yyzbzhong@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: December 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)