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

• Sponsor: Cutting Edge SAS (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05561478
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Anticipated Duration (Months): 19.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Surgery; IOL	Device: Implantation of Synthesis Plus IOL (control device); Device: Implantation of Synthesis Plus Toric IOL (investigational device)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 72 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
• Actual Study Start Date: Oct 10, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Test device (Synthesis Plus Toric) Requiring bilateral cataract surgery with pre-existing astigmatism	Device: Implantation of Synthesis Plus Toric IOL (investigational device); Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.
Control device (Synthesis Plus) Requiring bilateral cataract surgery	Device: Implantation of Synthesis Plus IOL (control device); Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.

Outcome Measures

Primary Outcome Measures

1. DCIVA at 66 cm [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 Outcome Measures

1. Monocular UDVA [1 month]

   distance

2. Monocular BCDVA [1 month]

   distance

3. Monocular UIVA [1 month]

   66 cm

4. Monocular DCIVA [1 month]

   66 cm

5. Refraction [1 month]

   subjective

6. Potential complications [1 month]

   postoperative

7. Rotational stability [Peroperatively, day 0, Month 1]

   in degrees

8. Subjective quality of vision [1 month]

   PROM

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient older than 50 years old

• Patient requiring bilateral cataract surgery

• Regular corneal astigmatism >0.5D measured by PENTACAM (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 Pentacam (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.

• Amblyopia with a visual acuity potential of less than 5/10

• IOL power needed outside the available IOL spherical diopter range: 5 to 32D

• Difficulty for cooperation (distance from their home, general health condition)

• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)

• Irregular astigmatism

• Subject with postoperative astigmatism, expected > 0.75 D.

• Any ocular comorbidity

• History of ocular trauma or prior ocular surgery including refractive procedures

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)

• Patients with chronic uveitis

• Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mm in photopic conditions))

• Narrow anterior chambers (ACD ≤ 2.5 mm)

• Any corneal pathology potentially affecting the topography (eg. Keratoconus),

• Monophthalma patients

• Phacodonesis

Exclusion criteria:

• Complicated surgery

• Inability to place the intraocular lens safely at the location planned

• Subjects with zonular laxity

• Postoperative endophthalmitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VISIS	Perpignan		France	66000

Sponsors and Collaborators

• Cutting Edge SAS

Investigators

• Principal Investigator: Boris Dethinne, MD, Visis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cutting Edge SAS
• ClinicalTrials.gov Identifier: NCT05561478
• Other Study ID Numbers: 2021-A02415-36
• First Posted: Sep 30, 2022
• Last Update Posted: Dec 14, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Dec 14, 2022