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Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane

Evaluation of Intraoperative Slow-release Dexamethasone Implant Used During Vitrectomy for Epiretinal Membrane

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05416827
Enrollment
30
Registered
2022-06-13
Start date
2022-06-15
Completion date
2022-09-15
Last updated
2022-06-13

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

Conditions

Epiretinal Membrane

Keywords

Epiretinal Membrane; Ozurdex; PPV

Brief summary

Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. PPV is generally successful at improving visual acuity (VA) and/or metamorphopsia. At times, however, visual recovery can be hindered by macular edema in the post-vitrectomy period. Ozurdex can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Detailed description

Small gauge pars plana vitrectomy (PPV) with membrane peeling is used to successfully treat macular epiretinal membranes (ERMs) with a postoperative improvement of visual acuity in the majority of cases. Traditionally, the treatment of ERMs has been performed purely by peeling the membrane mechanically and then waiting for the intraretinal edema to resolve spontaneously. In the last few years, some publications raised the possibility that triamcinolone acetonide (TA),given as an intravitreal injection at the end of surgery, can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs that has anti-inflammatory and immunosuppressant activity 30 times that of cortisol and 6 times that of triamcinolone. As the postoperative cystoid macular edema usually peaks 4 to 6 weeks after surgery the difference in the half life can be significant and explained the results in past publications. While the use of intravitreal TA as an adjuvant to PPV with membrane peel showed conflicting results. Only few publications demonstrated the effectiveness of Ozurdex in the treatment of macular edema in a vitrectomized eye, after ERM removal.So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Interventions

Epiretinal membrane eyes underwent PPV combined with Ozurdex implant

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with a visually significant (BCVA\<20/50) idiopathic epiretinal membrane. * ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.

Exclusion criteria

* concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration). * secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.

Design outcomes

Primary

MeasureTime frameDescription
CMTfrom preoperation to 3 months follow-upcentral macular thickness
IOPfrom preoperation to 3 months follow-upintraocular pressure
BCVAfrom preoperation to 3 months follow-upbest-corrected visual acuity

Contacts

Primary ContactJinfeng Qu, MD
Jinfeng_QuPKU@163.com+861088326666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026