Health TrialsbyHealthPanel

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

ConditionsCataractSurgeryIOL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorCutting Edge SAS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Complicated surgery

Inability to place the intraocular lens safely at the location planned

Subjects with zonular laxity

Postoperative endophthalmitis

Trial population

Patient requiring bilateral cataract surgery

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Implantation of Synthesis Plus IOL (control device)

    Device

    Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.

  • Implantation of Synthesis Plus Toric IOL (investigational device)

    Device

    Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Test device (Synthesis Plus Toric)1 intervention
Group B: Control device (Synthesis Plus)1 intervention

Trial outcomes

Primary outcomes

1

DCIVA at 66 cm

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

Time frame
1 month

Secondary outcomes

1

Monocular UDVA

distance

Time frame
1 month
2

Monocular BCDVA

distance

Time frame
1 month
3

Monocular UIVA

66 cm

Time frame
1 month
4

Monocular DCIVA

66 cm

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cutting Edge SAS

Lead sponsor

Source ClinicalTrials.gov
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