Visual Outcomes After Presbyopic Lens Exchange

Presbyopia Clinical Trial

— RELAX  

Official title:

Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790592
• Other study ID #: LISA tri 839MP BER-401-18
• Status: Completed
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: July 2020
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Compare preoperative and postoperative Corrected distance visual acuity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• trifocal IOL
intraocular lens

Locations

Country	Name	City	State
Germany	Augenzentrum Michelfeld	Michelfeld

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected distance visual acuity	preoperative and postoperative Corrected distance visual acuity will be assessed	4 to 6 months postop