Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT06567834
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs
Sponsor:
Empire Eye and Laser Center
Organization:
Study Overview
Official Title:
Clinical Evaluation of Violet Light Filtration and High-resolution Lathing on a Diffractive Extended Depth of Focus Intraocular Lens (IOL)
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to compare the Tecnis Symfony Optiblue intraocular lens implant to the Tecnis Symfony intraocular lens implant in patients over 22 years old with cataracts in both eyes. The main questions it aims to answer are:
Which lens has less nighttime side effects? Which lens has higher patient satisfaction?
Participants will undergo a minimum of 7 study visits where they will complete a variety of vision tests and vision questionnaires.
Which lens has less nighttime side effects? Which lens has higher patient satisfaction?
Participants will undergo a minimum of 7 study visits where they will complete a variety of vision tests and vision questionnaires.
Detailed Description:
This is 6 month, prospective, single center, subject/evaluator masked, bilateral, randomized clinical investigation of the TECNIS Symfony Model ZXR00V/ ZXW150 IOLs versus the TECNIS Symfony Model ZXR00/ZXT150 control IOL.
The study will enroll approximately 60 subjects to achieve approximately 54 randomized and bilaterally implanted subjects, resulting in approximately 25 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZXR00V/ZXW150 or the ZXR00/ ZXT150 control IOL. The eye implanted first will be considered the primary study eye.
Surgeons will perform routine, small-incision cataract surgery and implant the study lenses using an implantation system qualified by the respective manufacturer for use with that IOL. The target for refractive outcomes will be emmetropia for both eyes.
All subjects will undergo a minimum of 7 study visits: Preoperative for both eyes; Operative for each eye; 1 week first eye and second eye, 1 month and 6 month visits for both eyes together.
The primary endpoint is patient reported nighttime dysphotopsia symptoms as measured by the PRVSQ v2 questionnaire.
The secondary endpoints are 25% low contrast visual acuity with glare and patient satisfaction.
OTHER ENDPOINTS
* Monocular photopic uncorrected distance visual acuity (UCDVA)
* Binocular UCDVA and uncorrected near visual acuity (UCNVA) at 40 cm
* 10% and 25% low contrast acuity without glare
* Residual refractive error
* Natural binocular reading distance
* Distance of subjective near blur
* Lens findings/complications
* Spectacle use
* Other ocular/visual symptoms (non-directed chief complaint)
* Patient satisfaction and recommendation
* Time with physician in exam room
The study will enroll approximately 60 subjects to achieve approximately 54 randomized and bilaterally implanted subjects, resulting in approximately 25 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZXR00V/ZXW150 or the ZXR00/ ZXT150 control IOL. The eye implanted first will be considered the primary study eye.
Surgeons will perform routine, small-incision cataract surgery and implant the study lenses using an implantation system qualified by the respective manufacturer for use with that IOL. The target for refractive outcomes will be emmetropia for both eyes.
All subjects will undergo a minimum of 7 study visits: Preoperative for both eyes; Operative for each eye; 1 week first eye and second eye, 1 month and 6 month visits for both eyes together.
The primary endpoint is patient reported nighttime dysphotopsia symptoms as measured by the PRVSQ v2 questionnaire.
The secondary endpoints are 25% low contrast visual acuity with glare and patient satisfaction.
OTHER ENDPOINTS
* Monocular photopic uncorrected distance visual acuity (UCDVA)
* Binocular UCDVA and uncorrected near visual acuity (UCNVA) at 40 cm
* 10% and 25% low contrast acuity without glare
* Residual refractive error
* Natural binocular reading distance
* Distance of subjective near blur
* Lens findings/complications
* Spectacle use
* Other ocular/visual symptoms (non-directed chief complaint)
* Patient satisfaction and recommendation
* Time with physician in exam room
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: