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OpenTrials
Completed

NCT Number: NCT03356847

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitting of ocular implant

Device

Removal of natural lens and replacement with a SISA monofocal intraocular implant

Primary outcomes

  1. Rotational stability of SISA monofocal implant following cataracts surgery

    Time frame: 4 Months

    rotation in degrees measured by Labview software

Secondary outcomes

  1. Rotational stability of SISA monofocal implant following cataracts surgery

    Time frame: Day 0

    rotation in degrees measured by Labview software

  2. Rotational stability of SISA monofocal implant following cataracts surgery

    Time frame: Day 7

    rotation in degrees measured by Labview software

  3. Rotational stability of SISA monofocal implant following cataracts surgery

    Time frame: 1 Month

    rotation in degrees measured by Labview software

  4. Centering of SISA monofocal implant

    Time frame: Day 0

    Distance in mm between centers of the coreal and optic ellipses

  5. Centering of SISA monofocal implant

    Time frame: Day 7

    Distance in mm between centers of the coreal and optic ellipses

  6. Centering of SISA monofocal implant

    Time frame: Month 1

    Distance in mm between centers of the coreal and optic ellipses

  7. Centering of SISA monofocal implant

    Time frame: Month 4

    Distance in mm between centers of the coreal and optic ellipses

  8. Refractive precision

    Time frame: Day 7

    Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters

  9. Refractive precision

    Time frame: Month 1

    Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters;

  10. Refractive precision

    Time frame: Month 4

    Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters

  11. Visual acuity with and without correction

    Time frame: Day 7

    Early Treatment Diabetic Retinopathy Study scale, logMAR

  12. Visual acuity with and without correction

    Time frame: Month 1

    Early Treatment Diabetic Retinopathy Study scale, logMAR

  13. Visual acuity with and without correction

    Time frame: Month 4

    Early Treatment Diabetic Retinopathy Study scale, logMAR

  14. Perioperative complications

    Time frame: Day 0

    Yes/no

  15. Postoperative complications

    Time frame: Day 7

    Yes/no

  16. Occurrence of undesirable events,

    Time frame: Day 0

    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,

  17. Occurrence of undesirable events,

    Time frame: Day 7

    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,

  18. Occurrence of undesirable events,

    Time frame: Month 1

    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,

  19. Occurrence of undesirable events,

    Time frame: Month 7

    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,

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: SISALens

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2017
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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