Acute effects of intravitreal aflibercept injections on intraocular pressure in vitrectomized and silicone-oil-filled eyes (NH_SiOP)

Study identification

• EU PAS number:
  EUPAS1000000811
• Study ID:
  1000000811
• Official title and acronym:
  Acute effects of intravitreal aflibercept injections on intraocular pressure in vitrectomized and silicone-oil-filled eyes (NH_SiOP)
• DARWIN EU® study:
  No
• Study countries:
  Hungary
• Study description:
  A prospective, single-center, single-blind interventional cohort study was conducted from March 2022 to February 2025. After obtaining informed consent, patients requiring IVA were enrolled in one of the three study arms and analyzed. The G-SiO group included previously vitrectomized eyes that had undergone SiO tamponade (Oxane 1300, Bausch & Lomb, Bridgewater, NJ, USA). The G-PPV group consisted of previously vitrectomized eyes with 23G pars plana vitrectomy (PPV) surgery performed more than 3 months before enrollment, did not have SiO tamponade, or had undergone prior SiO tamponade. The G-NVIT group included eyes with intact vitreous bodies. Being treatment-naïve to IVIs was not a prerequisite for participating in the trial, whereas all participants’ eyes were treatment-naïve to antiglaucoma medications (not even temporary IOP lowering treatment was administered following SiO implantation or PPV surgery) and showed no signs of glaucomatous optic nerve disease.; The Ethics Committee of the University of Szeged reviewed and approved the trial (Protocol no. NH_SiOP-001, Reference no. 168/2022-SZTE RKEB). The study was conducted in accordance with the tenets of the Declaration of Helsinki.; If both eyes were eligible, both were enrolled in the study, as the treatment method did not differ among the cohorts.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Ophthalmology, University of Szeged

Study timelines

Date when funding contract was signed

Actual:01/03/2022

Study start date

Actual:01/03/2022

Data analysis start date

Actual:03/03/2025

Date of final study report

Actual:03/03/2025

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable