Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecnis Synergy ZFR00 IOL | Experimental | Tecnis Synergy ZFR00 IOL will be implanted in the patient's eye during cataract surgery. |
|
| Tecnis Symfony ZXR00 IOL | Placebo Comparator | Tecnis Symfony ZXR00 IOL will be implanted in the patient's eye during cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery | Procedure | The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual quality | OPD-scan measurement. Higher-order aberration, tilt and decentration will be recorded. | 3 months postoperatively |
| defocus curve | Best distance visual acuity varied from - 5.00 to + 2.00 D in steps of 0.50 D under photopic conditions was recorded. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyang Zhong, MD. | Contact | +8618868125901 | yyzbzhong@zju.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center of the Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310058 | China |
There is not a plan to make IPD available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| cataract surgery | Procedure | The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00). |
|
|
| 3 months postoperatively |
| contrast sensitivity | Contrast sensitivity will be converted to logarithmic scale before analysis and referred to as log-contrast sensitivity. | 3 months postoperatively |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided