A randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DMEC).

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510091-31-00

Enrollment

120

Registered

2024-10-15

Start date

2022-12-02

Completion date

Unknown

Last updated

2024-10-15

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

Conditions

Fuchs dystrophy

Brief summary

• Central macular thickness and macular cysts on optical coherence tomography

Detailed description

• Laser flare, • Peroperative factors, e.g. operation time (minutes), iris lesion (none, some, much), pigment loss (none, some, much), intraocular manipulation (none, some, much), • IOP in mmHg (applanation and iCare), • Corrected distance visual acuity (in logMAR), • Corneal endothelial cell density (measured with confocal microscopy, in cells/mm2)

Interventions

DRUGNEVANAC 3 mg/ml eye drops

DRUGsuspension

DRUGSpersadex 1 mg/ml øyedråper

DRUGoppløsning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Central macular thickness and macular cysts on optical coherence tomography	—

Secondary

Measure	Time frame
• Laser flare, • Peroperative factors, e.g. operation time (minutes), iris lesion (none, some, much), pigment loss (none, some, much), intraocular manipulation (none, some, much), • IOP in mmHg (applanation and iCare), • Corrected distance visual acuity (in logMAR), • Corneal endothelial cell density (measured with confocal microscopy, in cells/mm2)	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026