Influence of Posterior Vitreous Detachment on Retinal Detachment After Lens Surgery in Myopic Eyes (MYOPRED)

March 10, 2026 updated by: Prim. Prof. Dr. Oliver Findl, MBA

Phacoemulsification with implantation of posterior chamber lenses represents the gold standard of care for patients needing lens surgery, but there is an increased risk of developing pseudophakic retinal detachment after surgery. Especially myopic patients have an even higher risk of pseudophakic retinal detachment compared to the general population.

The aim of this multicenter study is to document the presence and/or post-operative development of posterior vitreous detachment (PVD) and to assess its influence on the incidence of retinal detachment (RD) in myopes in a time period of three and five years after lens surgery.

618 eyes of patients scheduled for regular lens surgery will be included, defined by an axial length of 25.0 mm or more. To examine the vitreous status, all patients will receive a comprehensive eye examination pre-operatively, including funduscopy with assessment of a Weiss ring and optical coherence tomography (OCT). Patients will be divided into two groups, group A with pre-operative complete PVD and group B with no/partial PVD. Group A will be invited for one follow-up visit (two months post-operatively) followed up by telephone interviews at one, two, three and five years after surgery to determine occurrence of pseudophakic retinal detachment. Group B will be invited for follow-up examinations at two months, six months and one year after surgery to document occurrence of PVD (if a PVD is present at one of the follow-ups, no more visits are necessary). Two, three and five years after surgery, all patients from group B will be interviewed by telephone, as in group A, to document the occurrence of pseudophakic retinal detachment.

In the recent literature the association between the occurrence of PVD pre-/post-operative and RD after lens surgery is well documented but not described for myopic patients. The results of this multicenter study should help to tackle the problem of RD prediction in myopic patients depending on their pre-operative vitreous status, especially in the setting of refractive lens exchange.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
609

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Oliver Findl, Prof. Dr.
  • Phone Number: +4319102157564
  • Email: office@viros.at

Study Locations

  • Austria
    • Vienna
      • Vienna, Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population: target 618. The participants will be selected by the clinical investigators at several ophthalmological centres in Austria, Belgium, Spain, Norway and the Netherlands. As the study population is already scheduled for cataract surgery / refractive lens exchange, recruitment will be performed directly in these centres at the pre-assessment visits. At this visit, optical biometry is performed and patients with suitable axial eye lengths will be screened. If all inclusion and no exclusion criteria are met the patients will be asked to participate in the trial.

Description

Inclusion Criteria:

  • Minimum 21 years of age
  • Patients scheduled for lens surgery with an axial eye length of 25.0 mm or more
  • Availability, willingness, sufficient cognitive awareness to comply with examination procedures
  • Ability to sign informed consent

Exclusion Criteria:

  • Patients with combined surgery (e.g. combined phacoemulsification and vitrectomy or trabeculectomy or DSAEK)
  • Patients with previous intraocular surgery (except any kind of laser surgery e.g. retinopexy, refractive laser surgery)
  • Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown aetiology, or any disease producing an inflammatory reaction in the eye
  • Any ophthalmological pathology with the potential to compromise the measurements (e.g. mature/very dense cataract, fixation difficulties)
  • Penetrating ocular trauma
  • Previous history of retinal detachment
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Patients participating in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A

Group A with pre-operative complete posterior vitreous detachment Group A will be invited for one follow-up visit (two months post-operatively) followed up by telephone interviews at one, two, three and five years after surgery to determine occurrence of pseudophakic retinal detachment.

Examinations: Best corrected Visual Acuity (BCVA) , SD-OCT (spectral domain optical coherence tomography), Ultrasound B-scan (substudy only), Slit lamp examination, telephone interview
Device: ultrasound, b-scan
Some selected centres will participate in a substudy. In the substudy population, if the vitreous cortex is not visible on OCT both in the study eye and the fellow eye, or if the OCT is of poor quality and most likely will not allow definite diagnosis, a B-scan ophthalmic ultrasound will be performed by an experienced examiner. The presence or absence of a PVD in the ultrasound measurement will be recorded in the case report form (CRF). If ultrasonography was not performed, allocation to the groups is based on the staging of the reading centre. Otherwise ultrasonography will be used for final diagnosis and group allocation if the reading centre classifies the OCT as not decisive.
B

Group B with no/partial PVD

Group B will be invited for follow-up examinations at two months, six months and one year after surgery to document occurrence of PVD (if a PVD is present at one of the follow-ups, no more visits are necessary). Two, three and five years after surgery, all patients from group B will be interviewed by telephone, as in group A, to document the occurrence of pseudophakic retinal detachment.

Examinations: BCVA, SD-OCT, Ultrasound B-scan (substudy only), Slit lamp examination, telephone interview
Device: ultrasound, b-scan
Some selected centres will participate in a substudy. In the substudy population, if the vitreous cortex is not visible on OCT both in the study eye and the fellow eye, or if the OCT is of poor quality and most likely will not allow definite diagnosis, a B-scan ophthalmic ultrasound will be performed by an experienced examiner. The presence or absence of a PVD in the ultrasound measurement will be recorded in the case report form (CRF). If ultrasonography was not performed, allocation to the groups is based on the staging of the reading centre. Otherwise ultrasonography will be used for final diagnosis and group allocation if the reading centre classifies the OCT as not decisive.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PVD status
Time Frame: 1 year
Number of patients with preoperative and/or post-operatively developed posterior vitreous detachment (PVD)
1 year
Incidence of RD
Time Frame: 5 years
Influence of PVD on the incidence of retinal detachment (RD) in myopes after lens surgery.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prim. Prof. Dr. Oliver Findl, MBA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Society of Cataract and Refractive Surgeons

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oliver Findl, Prof. Dr., Vienna Institute for Research in Ocular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Myopred

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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