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Evaluation of functional outcomes and OCT-biomarkers after intravitreal dexamethasone implant for postoperative cystoid macular edema in vitrectomized eyes

Evaluation of functional outcomes and OCT-biomarkers after intravitreal dexamethasone implant for postoperative cystoid macular edema in vitrectomized eyes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00018955
Enrollment
61
Registered
2019-12-10
Start date
2017-01-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

H35.3

Interventions

Group 1: Eyes that developed postoperative cystoid macular edema after retinal surgery (pars plana vitrectomy) were treated with Ozurdex® injections.

Sponsors

Augenklinik der LMU, Ludwig-Maximilians-Universität, München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Vitrectomized eyes that developed PCME after surgery including treatment with at least one Ozurdex® injection and a minimum follow-up period of 12 months. The indication for surgery was epiretinal membrane (ERM) or rhegmatogenous retinal detachment (RRD) without macular involvement. Ozurdex® injections were administrated between 01.06.2010 and 31.12.2016.

Exclusion criteria

Exclusion criteria: Previous vitrectomy, residual ERM, postoperative retinal detachment, further intraocular surgeries during the follow-up period, topical therapy with prostaglandins, any underlying retinal pathology that could affect the development of a cystoid macular edema (i.e. ocular trauma, age-related macular degeneration (AMD), diabetes, retinal vascular occlusion (RVO), vitreous hemorrhage, uveitis, silicon oil filling, or proliferative vitreoretinopathy.

Design outcomes

Primary

MeasureTime frame
1. Corrected visual acuity 12 months after the first Ozurdex® injection. 2. Central retinal thickness 12 months after the first Ozurdex® injection. 3. Role of OCT-morphology (including factors like subretinal fluid, intraretinal cysts, elipsoid zone disruption,etc.) on the final visual outcome.

Secondary

MeasureTime frame
1. Number of Ozurdex® injections within 12 months after the first injection 2. Time between surgery and first injection 3. Effect of previous treatments on visual acuity (12 months after the first injection)

Countries

Germany

Contacts

Public ContactEfstathios Vounotrypidis

Augenklinik der LMU, Ludwig-Maximilians-Universität, München

evounotr@med.lmu.de0049-89-440053811

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026