The aim of the study is to document the presence and/or post-operative development of PVD and to assess its influence on the incidence of PRD in myopic patients in a time period of three and five years after lens surgery.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in occurrence of retinal detachment in patients with
pre-operative posterior vitreous detachment (PVD) versus no/partial PVD within
three years after lens surgery.
Secondary outcome
The difference in occurrence of retinal detachment in patients with
pre-operative posterior vitreous detachment (PVD) versus no/partial PVD within
five years after lens surgery.
Background summary
Phacoemulsification with implantation of posterior chamber lenses represents
the gold standard of care for patients needing lens surgery. In most cases the
functional and clinical outcomes are excellent and high patient and clinician
satisfaction has been reported. However, there is a risk of developing
complications such as pseudophakic retinal detachment (PRD) after surgery.
Especially, myopic patients have an increased risk of PRD compared with the
general population.
Posterior vitreous detachment (PVD) represents one of the main possible changes
after lens exchange surgery and appears to have an effect on the development of
rhegmatogenous retinal detachment (RRD). There are several theories about the
increased incidence of PVD after cataract surgery. After the extraction of the
lens, the size of the volume of the posterior segment increases due to
replacement of the thick crystalline lens with a thin intraocular lens. This in
turn triggers PVD. Changes in the anterior vitreous after surgery due to an
inflammatory reaction may cause peripheral pseudophakic retinal breaks,
resulting in PRD. As a consequence of forward movements of the vitreous,
dynamic traction at the posterior border of the vitreous base can occur which
plays an important role in retinal tear formation and retinal detachment.
PRD is an important vision-threatening complication of cataract surgery. RRD in
the general population (without ocular surgery) is estimated to occur at a rate
between 0.0061% and 0.0179% per year. RRD incidence after phacoemulsification
(=PRD), on the other hand, is higher and is estimated to vary between 0.0% and
3.6% over a follow up period between 4 months and 10 years. More recent studies
have further defined this range to be between 0.41% and 1.17% for a follow-up
period between 0 and 10 years. These numbers are estimated to be higher in
myopic eyes.
The time interval between cataract surgery and PRD occurrence ranges from 15 to
39 months, with 75% of post-operative PRD cases being expected to occur within
2 years after cataract surgery.
Recently it was shown with optical coherence tomography (OCT) that lens surgery
results in early PVD in a high proportion of patients.
Study objective
The aim of the study is to document the presence and/or post-operative
development of PVD and to assess its influence on the incidence of PRD in
myopic patients in a time period of three and five years after lens surgery.
Study design
Observational study.
Study burden and risks
As this study is purely observational and the performed examinations are not
used for decision-making and have no influence on the treatment strategy, the
patient*s risk is not increased due to study participation. All devices used in
this study are CE-marked and used within the intended use as described by the
manufacturer. OCT is a routinely used diagnostic tool with light exposures far
below the acceptable exposure threshold. Application does not bear any
additional risk for the patients included in this study.
Patients included in this study will not have a direct benefit from
participation. However, the influence of pre-operative and/or post-operative
developed PVD on the incidence of PRD in myopes is important to estimate the
potential risk of post-operative detachment under influence of PVD in myopic
patients. With the results of this clinical trial surgeons may be able to
better inform future myopic patients on their individual risk profile for
occurrence of post-operative RD after lens exchange surgery.
Heinrich-Collin-Straße 30
Wenen 1140
AT
Heinrich-Collin-Straße 30
Wenen 1140
AT
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03152747 |
| CCMO | NL67009.068.18 |