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Clinical Trials/NCT05561478
NCT05561478
Recruiting
Not Applicable

Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

Cutting Edge SAS1 site in 1 country72 target enrollmentOctober 10, 2022
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ConditionsCataractSurgeryIOL

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Cutting Edge SAS
Enrollment
72
Locations
1
Primary Endpoint
DCIVA at 66 cm
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.

Registry
clinicaltrials.gov
Start Date
October 10, 2022
End Date
October 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patient older than 50 years old
  • •Patient requiring bilateral cataract surgery
  • •Regular corneal astigmatism \>0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
  • •Expected postoperative astigmatism ≤ 0.75D diopter
  • •Corneal astigmatism ≤4D
  • •IOL spherical equivalent power requested between 15D and 25D
  • •Signed informed consent
  • •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • •Non inclusion Criteria:
  • •Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

DCIVA at 66 cm

Time Frame: 1 month

The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS

Secondary Outcomes

  • Monocular BCDVA(1 month)
  • Rotational stability(Peroperatively, day 0, Month 1)
  • Monocular UIVA(1 month)
  • Refraction(1 month)
  • Monocular DCIVA(1 month)
  • Monocular UDVA(1 month)
  • Potential complications(1 month)
  • Subjective quality of vision(1 month)

Study Sites (1)

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