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CataractSISALensNCT03356847

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

A study testing Fitting of ocular implant in people with Cataract, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A good efficacy as well as good rotary stability is expected with the ocular implant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
Fitting of ocular implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
29 Sep 2017to 11 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

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

Conditions
Cataract
Being tested
Fitting of ocular implant
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fitting of ocular implantDevice

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

Study groups in NCT03356847
Study groupRoleWhat they receive
SISA implantExperimentalNot described
Receives: Device: Fitting of ocular implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rotational stability of SISA monofocal implant following cataracts surgery

    rotation in degrees measured by Labview software

    Measured: 4 Months

Secondary outcomes (19)

  1. Rotational stability of SISA monofocal implant following cataracts surgery

    rotation in degrees measured by Labview software

    Measured: Day 0

  2. Rotational stability of SISA monofocal implant following cataracts surgery

    rotation in degrees measured by Labview software

    Measured: Day 7

  3. Rotational stability of SISA monofocal implant following cataracts surgery

    rotation in degrees measured by Labview software

    Measured: 1 Month

  4. Centering of SISA monofocal implant

    Distance in mm between centers of the coreal and optic ellipses

    Measured: Day 0

  5. Centering of SISA monofocal implant

    Distance in mm between centers of the coreal and optic ellipses

    Measured: Day 7

  6. Centering of SISA monofocal implant

    Distance in mm between centers of the coreal and optic ellipses

    Measured: Month 1

  7. Centering of SISA monofocal implant

    Distance in mm between centers of the coreal and optic ellipses

    Measured: Month 4

  8. Refractive precision

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

    Measured: Day 7

  9. Refractive precision

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

    Measured: Month 1

  10. Refractive precision

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

    Measured: Month 4

  11. Visual acuity with and without correction

    Early Treatment Diabetic Retinopathy Study scale, logMAR

    Measured: Day 7

  12. Visual acuity with and without correction

    Early Treatment Diabetic Retinopathy Study scale, logMAR

    Measured: Month 1

  13. Visual acuity with and without correction

    Early Treatment Diabetic Retinopathy Study scale, logMAR

    Measured: Month 4

  14. Perioperative complications

    Yes/no

    Measured: Day 0

  15. Postoperative complications

    Yes/no

    Measured: Day 7

  16. 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,

    Measured: Day 0

  17. 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,

    Measured: Day 7

  18. 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,

    Measured: Month 1

  19. 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,

    Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study start29 Sep 2017
  3. Primary completion11 Jul 2018
  4. Study completion11 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356847
Sponsor's protocol ID
IDIL/2017/DM-01
Acronym
SISALens
Status last verified
Nov 2017
First submitted
29 Sep 2017
Last updated
2 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Fitting of ocular implant in people with Cataract, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rotational stability of SISA monofocal implant following cataracts surgery (time frame: 4 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03356847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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