Research with human participants

Overview of medical research in the Netherlands

Secondary macular edema after Descemet*s Stripping Automated Endothelial Keratoplasty (DSAEK): a prospective, non-comparative study.

Published:
Last updated:

Quantification of the incidence of postoperative CME in DSAEK patients.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Retina, choroid and vitreous haemorrhages and vascular disorders
Study type
Observational non invasive

ID

NL-OMON32110

Source

ToetsingOnline

Brief title

Post-DSAEK CME

Condition

  • Retina, choroid and vitreous haemorrhages and vascular disorders

Synonym

macular edema

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis Prof. Dr. H.J. Flieringa.

Intervention

Keyword :
cystoid macular edema, DSAEK, optical coherence tomography, risk factors

Outcome measures

Primary outcome

Incidence of CME at 1, 3 and 6 months after DSAEK.

Secondary outcome

Relationship risk factors and pre-op macular condition with post-op CME.

Background summary

Macular edema (ME) is a possible complication following keratoplastic surgery
which affects visual acuity outcome. Because DSAEK has been introduced
relatively recently, the incidence of ME and its effect on longterm outcome
remains largely unknown.

Study objective

Quantification of the incidence of postoperative CME in DSAEK patients.

Study design

Prospective, non-comparative trial.

Study burden and risks

Study-related measurements will be performed at the time of regular clinical
visits, and will take about 50 minutes extra time. Participants do not benefit
from study results. Risks are negligible.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
3011 BH Rotterdam
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
3011 BH Rotterdam
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- age >= 18 years of age
- informed consent
- Fuchs* endothelial dystrophy or Pseudophakic Bullous Keratopathy requiring DSAEK
- cornea that allows preoperative OCT imaging
- pseudophakic

Exclusion criteria

- previous ocular surgery that could influence visual outcome
(except uneventful cataract surgery)
- other macular or inflammatory disease that could influence the incidence of CME
(eg. diabetic retinopathy, diabetic maculopathy, retinal vein occlusion, uveitis)
- ocular disease that could influence visual outcome
(except Fuchs`endothelial dystrophy or PBK)
- other ocular surgery planned within 12 months following inclusion in this study
- systemic therapy that could influence the occurrence of macular edema
(eg. Avandia, Acetazolamide)

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
30
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

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
CCMO NL23536.078.08