NCT03790592

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 14, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

December 28, 2018

Last Update Submit

July 15, 2020

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Corrected distance visual acuity

    preoperative and postoperative Corrected distance visual acuity will be assessed

    4 to 6 months postop

Study Arms (1)

trifocal IOL

EXPERIMENTAL

patients implanted with a trifocal intraocular lens

Device: trifocal IOL

Interventions

trifocal IOLDEVICE

intraocular lens

trifocal IOL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
  • Patients of any gender, aged 18 years or older
  • Assured follow-up examinations
  • Post-operative astigmatism ≤ 0.75 Diopter
  • IOL implanted into the capsular bag with trifocal IOL in both eyes
  • Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes
  • Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR
  • Normal findings in the medical history and physical examination

You may not qualify if:

  • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
  • Patients whose freedom is impaired by administrative or legal order
  • Concurrent participation in another drug or device investigation that affects patients vision
  • Signs of early cataract in either eye
  • Preoperative monocular and binocular CDVA worse than 0.2 logMAR
  • Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye
  • Cataract of any grade
  • Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye
  • 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.)
  • Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
  • Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
  • 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.
  • Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
  • Patient expected to require retinal laser treatment before 6 month follow-up visit
  • Patient require refractive laser treatment / refractive laser touch-up before 6 month follow up visit
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenzentrum Michelfeld

Michelfeld, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35948879DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2018

First Posted

December 31, 2018

Study Start

May 14, 2019

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)