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Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery (SISALens)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fitting of ocular implant
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient must be available for 6 months follow-up
  • The patient it aged at least 18 years
  • Patient requires surgery for cataracts with removal of the opacified natural lens and replacement with the SISA implant, according to standard procedure
  • The surgery is elective
  • The patient has clear and non-pathological corneas
  • The patient needs an implant strength (LIO) between +10D and +30D
  • Corneal astigmatism less than or equal to 1.50D in the eye to be operated (or cataract eye

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The patient is under safeguard of justice or state guardianship
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is pregnant or breastfeeding
  • The patient has other ocular comorbidities with poor visual acuity prognosis postoperatively
  • Previous ocular trauma or surgery
  • Dilation of the pupil <7mm with mydriatic drugs
  • Implantation with a rhexis that does not cover the optic of the implant by more than 1 cadranel

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SISA implant

Arm Description

Outcomes

Primary Outcome Measures

Rotational stability of SISA monofocal implant following cataracts surgery
rotation in degrees measured by Labview software

Secondary Outcome Measures

Rotational stability of SISA monofocal implant following cataracts surgery
rotation in degrees measured by Labview software
Rotational stability of SISA monofocal implant following cataracts surgery
rotation in degrees measured by Labview software
Rotational stability of SISA monofocal implant following cataracts surgery
rotation in degrees measured by Labview software
Centering of SISA monofocal implant
Distance in mm between centers of the coreal and optic ellipses
Centering of SISA monofocal implant
Distance in mm between centers of the coreal and optic ellipses
Centering of SISA monofocal implant
Distance in mm between centers of the coreal and optic ellipses
Centering of SISA monofocal implant
Distance in mm between centers of the coreal and optic ellipses
Refractive precision
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
Refractive precision
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters;
Refractive precision
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
Visual acuity with and without correction
Early Treatment Diabetic Retinopathy Study scale, logMAR
Visual acuity with and without correction
Early Treatment Diabetic Retinopathy Study scale, logMAR
Visual acuity with and without correction
Early Treatment Diabetic Retinopathy Study scale, logMAR
Perioperative complications
Yes/no
Postoperative complications
Yes/no
Occurrence of undesirable events,
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Occurrence of undesirable events,
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Occurrence of undesirable events,
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Occurrence of undesirable events,
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,

Full Information

First Posted
September 29, 2017
Last Updated
August 1, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03356847
Brief Title
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Acronym
SISALens
Official Title
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A good efficacy as well as good rotary stability is expected with the ocular implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SISA implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fitting of ocular implant
Intervention Description
Removal of natural lens and replacement with a SISA monofocal intraocular implant
Primary Outcome Measure Information:
Title
Rotational stability of SISA monofocal implant following cataracts surgery
Description
rotation in degrees measured by Labview software
Time Frame
4 Months
Secondary Outcome Measure Information:
Title
Rotational stability of SISA monofocal implant following cataracts surgery
Description
rotation in degrees measured by Labview software
Time Frame
Day 0
Title
Rotational stability of SISA monofocal implant following cataracts surgery
Description
rotation in degrees measured by Labview software
Time Frame
Day 7
Title
Rotational stability of SISA monofocal implant following cataracts surgery
Description
rotation in degrees measured by Labview software
Time Frame
1 Month
Title
Centering of SISA monofocal implant
Description
Distance in mm between centers of the coreal and optic ellipses
Time Frame
Day 0
Title
Centering of SISA monofocal implant
Description
Distance in mm between centers of the coreal and optic ellipses
Time Frame
Day 7
Title
Centering of SISA monofocal implant
Description
Distance in mm between centers of the coreal and optic ellipses
Time Frame
Month 1
Title
Centering of SISA monofocal implant
Description
Distance in mm between centers of the coreal and optic ellipses
Time Frame
Month 4
Title
Refractive precision
Description
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
Time Frame
Day 7
Title
Refractive precision
Description
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters;
Time Frame
Month 1
Title
Refractive precision
Description
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
Time Frame
Month 4
Title
Visual acuity with and without correction
Description
Early Treatment Diabetic Retinopathy Study scale, logMAR
Time Frame
Day 7
Title
Visual acuity with and without correction
Description
Early Treatment Diabetic Retinopathy Study scale, logMAR
Time Frame
Month 1
Title
Visual acuity with and without correction
Description
Early Treatment Diabetic Retinopathy Study scale, logMAR
Time Frame
Month 4
Title
Perioperative complications
Description
Yes/no
Time Frame
Day 0
Title
Postoperative complications
Description
Yes/no
Time Frame
Day 7
Title
Occurrence of undesirable events,
Description
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Time Frame
Day 0
Title
Occurrence of undesirable events,
Description
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Time Frame
Day 7
Title
Occurrence of undesirable events,
Description
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Time Frame
Month 1
Title
Occurrence of undesirable events,
Description
Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted,
Time Frame
Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient must be available for 6 months follow-up The patient it aged at least 18 years Patient requires surgery for cataracts with removal of the opacified natural lens and replacement with the SISA implant, according to standard procedure The surgery is elective The patient has clear and non-pathological corneas The patient needs an implant strength (LIO) between +10D and +30D Corneal astigmatism less than or equal to 1.50D in the eye to be operated (or cataract eye Exclusion Criteria: The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study The patient is under safeguard of justice or state guardianship The subject refuses to sign the consent It is impossible to give the subject informed information The patient is pregnant or breastfeeding The patient has other ocular comorbidities with poor visual acuity prognosis postoperatively Previous ocular trauma or surgery Dilation of the pupil <7mm with mydriatic drugs Implantation with a rhexis that does not cover the optic of the implant by more than 1 cadranel
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery

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