Visual Outcomes After Presbyopic Lens Exchange (RELAX)

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

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: trifocal IOL

Detailed Description

Compare preoperative and postoperative Corrected distance visual acuity

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Michelfeld, Germany
    • Augenzentrum Michelfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: trifocal IOL; patients implanted with a trifocal intraocular lens	Device: trifocal IOL; intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected distance visual acuity	preoperative and postoperative Corrected distance visual acuity will be assessed	4 to 6 months postop

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Publications and helpful links

General Publications

• Fernandez J, Alfonso Sanchez JF, Nieradzik M, Valcarcel B, Burguera N, Kapp A. Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract. BMC Ophthalmol. 2022 Aug 10;22(1):341. doi: 10.1186/s12886-022-02556-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 14, 2019
• Primary Completion (ACTUAL): December 9, 2019
• Study Completion (ACTUAL): December 9, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (ACTUAL): December 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: LISA tri 839MP BER-401-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No