PresbyopiaRELAXNCT03790592
Visual Outcomes After Presbyopic Lens Exchange
A study testing trifocal IOL in people with Presbyopia, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- trifocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 14 May 2019to 9 Dec 2019
- 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
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Current Systemic or ocular pharmacotherapy that effects patients vision
- Floppy iris syndrome
- Monophthalmic patient
- Previous corneal surgery
- Previous use of cytotoxic drugs or total body irradiation
- Dementia
- Uncontrolled glaucoma or Intraocular pressure (IOP) higher than 24 millimeter of mercury (mmHg) under ocular hypertension treatment
- Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
Compare preoperative and postoperative Corrected distance visual acuity
- Conditions
- Presbyopia
- Being tested
- trifocal IOL
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifocal IOLDevice
intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| trifocal IOL | Experimental | patients implanted with a trifocal intraocular lens Receives: Device: trifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected distance visual acuity
preoperative and postoperative Corrected distance visual acuity will be assessed
Measured: 4 to 6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start14 May 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790592
- Sponsor's protocol ID
- LISA tri 839MP BER-401-18
- Acronym
- RELAX
- Status last verified
- Jul 2020
- First submitted
- 28 Dec 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35948879
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT03790592
- Acronym / sponsor ID
- RELAX / LISA tri 839MP BER-401-18
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients
Detailed description
Compare preoperative and postoperative Corrected distance visual acuity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trifocal IOL | Experimental | Device: trifocal IOLpatients implanted with a trifocal intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trifocal IOLintraocular lens | Device | trifocal IOL |
Primary outcome
Corrected distance visual acuity
Time frame: 4 to 6 months postop
preoperative and postoperative Corrected distance visual acuity will be assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Derived from this study: PubMed 35948879Fernandez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trifocal IOL in people with Presbyopia, run by Carl Zeiss Meditec AG at 1 site in Germany.
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 8 inclusion and 23 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 16 Jul 2020. 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 Germany. 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?
Corrected distance visual acuity (time frame: 4 to 6 months postop). 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 NCT03790592, which also lists 1 linked publication.
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 16 Jul 2020.