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Effect of topical prednisolone and diclofenac on the morphology of Posterior Capsule Opacification

Effect of topical prednisolone and diclofenac on the morphology of Posterior Capsule Opacification

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004263-30-AT
Enrollment
30
Registered
2005-04-05
Start date
2005-05-10
Completion date
Unknown
Last updated
2018-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Ultracortenol Product Name: Ultracortenol Pharmaceutical Form: Eye drops* Trade Name: Voltaren Ophta Product Name: Voltaren Ophta Pharmaceutical Form: Eye drops*

Sponsors

Univ.-Prof. Dr. Oliver Findl Med. Univ. Wien
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - tear film problems - corneal pathology - dense vitreous opacities - pupil diameter of less than 5 mm after dilatation.

Design outcomes

Primary

MeasureTime frame
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: Change in number and size of Elschnig pearls (Posterior capsule opacification) (subjective assessment) Additional outcome variables Subjective description of morphological changes between images

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026