Research with human participants

Overview of medical research in the Netherlands

The post-cataract inflammatory reaction with combination therapy of topical steroid and NSAID.

Published:
Last updated:

Evaluation of the inflammatory reaction with NSAID and steroid prophylaxis.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Ocular infections, irritations and inflammations
Study type
Observational non invasive

ID

NL-OMON37669

Source

ToetsingOnline

Brief title

Post-cataract topical steroid & NSAID therapy

Condition

  • Ocular infections, irritations and inflammations

Synonym

ocular inflammatory reaction

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Nuts OHRA

Intervention

Keyword :
cataract, flare count, prohylaxis

Outcome measures

Primary outcome

Flare counts at baseline and post-op day 1, 3, 5, 7, 10, 14, 21, 30, 60 and 90.

Secondary outcome

Retinal thickness, visual acuity.

Background summary

Suppression of the inflammatory activity after cataract extraction may prevent
complications. Historically, corticosteroid eye drops have been standard
prophylaxis. It is hypothesized that the combination of NSAID and steroid eye
drops shows pharmacodynamic synergy.

Study objective

Evaluation of the inflammatory reaction with NSAID and steroid prophylaxis.

Study design

Observational pharmacodynamic.

Study burden and risks

Risks involved are considered to be small. For this part of the study patients
are selected by zip-code to minimize travel time to the hospital.

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.
- Caucasian.
- Informed consent.
- Post-op follow-up must be feasible.
- Living at address with zip code of Rotterdam or close vicinity.
- Cataract extraction performed.

Exclusion criteria

- Subcapsular posterior cataract (very soft, short phaco time).
- Brunescens or mature cataract (hard, long phaco time).
- Diabetes mellitus.
- Age-related macula degeneration.
- History of uveitis.
- Glaucoma.
- History of steroid response.
- Pre-operative synechiae anterior
- Systemic or topical steroid medication.
- Chemotherapy.
- Sickle cell anemia.
- Corneal complications.
- Keratoconjunctivitis sicca
- Rheumatoid arthritis
- HSV.

Design

Study phase :
4
Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Dexamethasone ratiopharm
Generic name :
dexamethasone
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
Nevanac
Generic name :
nepafenac
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
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
EudraCT EUCTR2011-006066-40-NL
CCMO NL39154.078.11