Research with human participants

Overview of medical research in the Netherlands

Does a preoperative subconjunctival injection of Dexamethason reduce the incidence of proliferative vitreoretinopathy in patients with ablatio retinae?

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON21185

Source

NTR

Brief title

N/A

Intervention

Outcome measures

Primary outcome

Incidence of proliferative vitreoretinopathy.

Secondary outcome

N/A

Background summary

N/A

Study objective

A preoperative subconjunctival injection of Dexamethason reduces the incidence of proliferative vitreoretinopathy in patients with ablatio retinae.

Study design

N/A

Intervention

Preoperative and postoperative subconjunctival injection of Dexamethasone (10 mg) or placebo.

Public
Oogziekenhuis Rotterdam,
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Scientific
Oogziekenhuis Rotterdam,
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl

Inclusion criteria

1. Primary rhegmatogenous retinal detachment;

2. No previous ablatio surgery.

Exclusion criteria

1. Diabetes mellitus;

2. Systemic steroids;

3. Steroid eye drops;

4. Steroid glaucoma responder.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
40
Type :
Actual

Positive opinion
Date :
Application type :
First submission

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
NTR-new NL159
NTR-old NTR194
Other : OZR-2001-09
ISRCTN ISRCTN31308983

Summary results

Bali E, Feron EJ, Peperkamp E, Veckeneer M, Mulder PG, van

Meurs JC. The effect of a preoperative subconjuntival injection of

dexamethasone on blood-retinal barrier breakdown following scleral

buckling retinal detachment surgery: a prospective randomized placebo-
controlled double blind clinical trial. Graefes Arch Clin Exp Ophthalmol.

2010; 248(7): 957-62. PMID: 20182883