DOI: 10.1002/nop2.70964 ISSN: 2054-1058

Eye Protection Chamber for Preventing Corneal Injury in Surgical Patients: Protocol for a Randomised Pilot and Feasibility Trial

Thalita Gomes do Carmo, Roberto de Souza, Anna Beatriz Justen dos Santos, Luana Faria Barbosa, Giovanna Oliveira de Marteloti, Maria Eduarda Maciel Palmares, Eduardo Melani Rocha, Patricia Rezende do Prado
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ABSTRACT

Aim

To assess the feasibility of conducting a definitive randomised trial comparing an eye protection chamber with standard microporous adhesive tape in adults undergoing general anaesthesia for surgery expected to last more than 120 min, and to obtain preliminary estimates of perioperative corneal‐injury event rates and device‐related outcomes.

Methods

This single‐centre, parallel‐group, assessor‐blinded, randomised pilot and feasibility trial will allocate participants using simple randomisation with a 1:1 allocation probability to either the control group (adhesive tape and lubricating eye drops) or the intervention group (lubricating eye drops and an eye protection chamber). Primary feasibility outcomes will include recruitment, retention and completeness of the planned corneal assessments, intervention adherence, device displacement/reapplication and safety. Corneal examinations using fluorescein staining and slit‐lamp assessment will be performed before induction of general anaesthesia ( T0 ), during the immediate postoperative period after completion of surgery and removal of the eye‐protection device ( T1 ), and 24 h after surgery ( T2 ). The incidence of any new corneal epithelial injury detected at T1 and/or T2 that was absent at T0 will be estimated as an exploratory clinical outcome. A pragmatic total sample of 120 participants will be retained to estimate feasibility parameters and preliminary event rates; the trial is not powered for confirmatory superiority testing.

Patient or Public Contribution

No patient or public involvement occurred in the development of this protocol. Nursing relevance: The trial is intended to inform the design of a definitive study and may support the development of evidence‐based perioperative eye‐protection protocols.

Trial Registration

Brazilian Registry of Clinical Trials (Registro Brasileiro de Ensaios Clínicos [ReBEC]) under UTN number U1111‐1285‐5334

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