HealthyNCT04967612

Visual Perception After Virtual Implantation

A study testing Virtual implantation in people with Healthy, run by Carl Zeiss Meditec AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluation of visual perception through diffractive optical lens designs by virtual implantation. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Virtual implantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteGermany
Study dates: 10 May 2021to 19 Aug 2021
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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects between and including 18 and 50 years of age;
Healthy eyes;
Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
Negative COVID19 screening test prior to every trial visit.

Who cannot join

Subjects of less than 18 or more than 50 years of age;
Monocular CDVA of dominant eye < 1.0 decimal (> 0.0 logMAR) without cycloplegia;
Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
Pseudophakic subjects;
Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;

Show all 11Show fewer

Pathologic miosis;
Intake of drugs affecting vision;
Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;
Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;
Hyperopes with more than +6 D refraction.

Trial locations and contacts

1 site in 1 country.

Germany1 site

JenVis Research
Jena, 07745

Other trials in Germany

About this study

Official title: Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.

Evaluation of visual perception through diffractive optical lens designs by virtual implantation.

Conditions: Healthy
Being tested: Virtual implantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual implantationOther
Temporary placement of virtual optical lens in the crystalline lens plane.

Study groups in NCT04967612
Study group	Role	What they receive
Virtual implantation of diffractive optical lens design A	Experimental	Not described Receives: Other: Virtual implantation
Virtual implantation of diffractive optical lens design B	Experimental	Not described Receives: Other: Virtual implantation
Virtual implantation of diffractive optical lens design C	Experimental	Not described Receives: Other: Virtual implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Corrected distance visual acuity
Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs
Measured: during the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 202119 Aug 2021

First posted19 Jul 2021
Study start10 May 2021
Primary completion19 Aug 2021
Study completion19 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04967612
Sponsor's protocol ID: PJV2002
Status last verified: Oct 2021
First submitted: 7 Jul 2021
Last updated: 22 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.
ClinicalTrials.gov ID: NCT04967612
Acronym / sponsor ID: PJV2002
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
Study start: 10 May 2021 (actual)
Primary completion: 19 Aug 2021 (actual)
Study completion: 19 Aug 2021 (actual)
First posted: 19 Jul 2021 (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 visual perception through diffractive optical lens designs by virtual implantation.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Virtual implantation of diffractive optical lens design A	Experimental	Other: Virtual implantation
Virtual implantation of diffractive optical lens design B	Experimental	Other: Virtual implantation
Virtual implantation of diffractive optical lens design C	Experimental	Other: Virtual implantation

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female subjects between and including 18 and 50 years of age;
Healthy eyes;
Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
Negative COVID19 screening test prior to every trial visit.

Key exclusion criteria (11 listed)

Subjects of less than 18 or more than 50 years of age;
Monocular CDVA of dominant eye < 1.0 decimal (> 0.0 logMAR) without cycloplegia;
Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
Pseudophakic subjects;

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
Virtual implantationTemporary placement of virtual optical lens in the crystalline lens plane.	Other	Virtual implantation of diffractive optical lens design A, Virtual implantation of diffractive optical lens design B, Virtual implantation of diffractive optical lens design C

Primary outcome

Corrected distance visual acuity
Time frame: during the intervention
Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs

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 22 Oct 2021.

Related trials for Healthy

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples

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.

W Sickenberger, Prof principal investigator

JenVis Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual implantation in people with Healthy, 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 5 inclusion and 11 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 22 Oct 2021. 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: during the intervention). 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 NCT04967612.

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 22 Oct 2021.