Effect of topical prednisolone and diclofenac on the morphology of Posterior Capsule Opacificatio
Phase 1
- Conditions
- After-cataract or posterior capsule opacification (PCO) remains the most common long-term complication of modern cataract-surgery. Recent investigations showed a significant alteration of Elschnig pearls and signs of reorganisation during a period of weeks. Little is known about the pharmaceutical influence on these processes.
- Registration Number
- EUCTR2004-004263-30-AT
- Lead Sponsor
- niv.-Prof. Dr. Oliver Findl Med. Univ. Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
-Pseudophakic eye with dense regeneratory PCO
-Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-tear film problems
-corneal pathology
-dense vitreous opacities
-pupil diameter of less than 5 mm after dilatation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Aim of this study is to observe and document the effect of steroidal and nonsteroidal anti-inflammatory treatment on the morphological changes of PCO.;Secondary Objective: ;Primary end point(s): Main outcome variable:<br>Change in number and size of Elschnig pearls (Posterior capsule opacification) (subjective assessment)<br>Additional outcome variables<br>Subjective description of morphological changes between images<br>
- Secondary Outcome Measures
Name Time Method