Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567834
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs
Sponsor:
None
Organization:
None
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:
No
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 subjectevaluator masked bilateral randomized clinical investigation of the TECNIS Symfony Model ZXR00V ZXW150 IOLs versus the TECNIS Symfony Model ZXR00ZXT150 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 ZXR00VZXW150 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 findingscomplications
Spectacle use
Other ocularvisual 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 ZXR00VZXW150 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 findingscomplications
Spectacle use
Other ocularvisual symptoms non-directed chief complaint
Patient satisfaction and recommendation
Time with physician in exam room
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None