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RELAX: Visual Outcomes After Presbyopic Lens Exchange

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Completed
CT.gov ID
NCT03790592
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
6.9
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients

Condition or Disease Intervention/Treatment Phase
  • Device: trifocal IOL
 N/A

Detailed Description

Compare preoperative and postoperative Corrected distance visual acuity

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)
Actual Study Start Date :
May 14, 2019
Actual Primary Completion Date :
Dec 9, 2019
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: trifocal IOL

patients implanted with a trifocal intraocular lens

Device: trifocal IOL
intraocular lens

Outcome Measures

Primary Outcome Measures

  1. Corrected distance visual acuity [4 to 6 months postop]

    preoperative and postoperative Corrected distance visual acuity will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent

  2. Patients of any gender, aged 18 years or older

  3. Assured follow-up examinations

  4. Post-operative astigmatism ≤ 0.75 Diopter

  5. IOL implanted into the capsular bag with trifocal IOL in both eyes

  6. Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes

  7. Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR

  8. Normal findings in the medical history and physical examination

Exclusion Criteria:

  1. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial

  2. Patients whose freedom is impaired by administrative or legal order

  3. Concurrent participation in another drug or device investigation that affects patients vision

  4. Signs of early cataract in either eye

  5. Preoperative monocular and binocular CDVA worse than 0.2 logMAR

  6. Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye

  7. Cataract of any grade

  8. Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye

  9. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, clinically significant anterior membrane dystrophies, poor pupil dilation, etc.)

  10. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)

  11. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)

  12. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.

  13. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus

  14. Patient expected to require retinal laser treatment before 6 month follow-up visit

  15. Patient require refractive laser treatment / refractive laser touch-up before 6 month follow up visit

  16. Current Systemic or ocular pharmacotherapy that effects patients vision

  17. Floppy iris syndrome

  18. Monophthalmic patient

  19. Previous corneal surgery

  20. Previous use of cytotoxic drugs or total body irradiation

  21. Dementia

  22. Uncontrolled glaucoma or Intraocular pressure (IOP) higher than 24 millimeter of mercury (mmHg) under ocular hypertension treatment

  23. Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient

Contacts and Locations

Locations

Site City State Country Postal Code
1 Augenzentrum Michelfeld Michelfeld Germany

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT03790592
Other Study ID Numbers:
  • LISA tri 839MP BER-401-18
First Posted:
Dec 31, 2018
Last Update Posted:
Jul 16, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Presbyopia

Study Results

No Results Posted as of Jul 16, 2020