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NCT Number: NCT07632326

Effects of Oxygen Cage Support During Cataract Surgery

Cataract is an ocular disorder resulting from lens opacity; it stands as the most common cause of preventable blindness worldwide and significantly impairs the quality of life in elderly individuals. Surgical treatment utilizing small-incision phacoemulsification is the most effective solution for cataracts. Cataract surgery is generally performed under local anesthesia, which requires patients to remain awake throughout the operation, thereby potentially increasing their anxiety experiences. Elevated anxiety not only reduces patient comfort but can also lead to alterations in physiological parameters and a prolongation of the operation time. Furthermore, it is observed that the surgical drapes used to maintain the sterility of the surgical field during the operation cause discomfort to the patient. The weight and positioning of these drapes can cover the patient's mouth and nose area during the ongoing surgery, creating a sensation of difficulty in breathing (dyspnea). In addition to these circumstances, standard oxygen support is provided to the patient during cataract surgery performed under local anesthesia. This support is administered nasally via an open-ended oxygen tubing from beneath the surgical drape, aiming to ease the patient's respiration. However, when the oxygen flow rate is increased based on the patient's needs, high-velocity and high-concentration oxygen administration is observed to cause mucosal dryness, which shortly triggers reflex-induced irritative coughing attacks. For these reasons, it is crucial to keep anxiety under control, provide oxygen to prevent hypoxia, and monitor physiological parameters during cataract surgery.

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Key information

Conditions

Cataract Anxiety Disorders Eye Diseases Lens Diseases Mental Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is designed as a mixed-methods research project comprising two distinct but interconnected phases. The quantitative phase utilizes a randomized controlled experimental design to evaluate the physiological and clinical efficacy of a newly developed Oxygen Support Cage material. The qualitative phase employs a descriptive phenomenological approach to explore patients' in-depth subjective experiences, comfort levels, and perceptions regarding the device.

Patients assigned to the intervention group will undergo cataract surgery with the integration of the 3D-printed, biocompatible Oxygen Support Cage. This device is positioned over the patient's head area to elevate the sterile surgical drapes, effectively preventing direct contact and weight pressure on the patient's face, mouth, and nose. Concurrently, supplemental oxygen will be delivered into the cage micro-environment. This setup aims to maintain an optimal, stable oxygen concentration without high-velocity nasal flow, thereby mitigating mucosal dryness and potential cough reflexes. Patients assigned to the control group will receive the standard hospital protocol for cataract surgery, where supplemental oxygen is administered nasally via open-ended oxygen tubing beneath standard surgical drapes without any cage support.

Physiological parameters (including blood pressure, heart rate, respiratory rate, oxygen saturation, and end-tidal carbon dioxide [EtCO2]) will be monitored and recorded chronologically at predefined intervals: 15 minutes before descending to the operating room (in the patient room), during specific intraoperative stages, and postoperatively in the recovery room. Anxiety levels and surgical durations will be documented accordingly.

Following the completion of the surgical procedures and quantitative data collection, a subset of participants from the intervention group will be invited to participate in semi-structured, face-to-face qualitative interviews. These interviews will focus on their sensory experiences, breathing comfort, confinement anxiety under the drapes, and overall satisfaction with the Oxygen Support Cage. By combining statistical findings with thematic analysis of patient narratives, the study aims to provide a holistic validation of the medical device's utility in clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate in the study voluntarily and provides informed consent
  • Aged 18 years or older
  • Having no hearing or cognitive impairments
  • Undergoing cataract surgery for the first time Exclusion Criteria
  • Conversion from local anesthesia to general anesthesia during the surgery
  • Patient's non-participation or refusal to complete the anxiety assessment during the surgery

Treatment and study plan

Oxygen Support Cage

Other

This intervention utilizes a uniquely structured, 3D-printed, and biocompatible Oxygen Support Cage designed specifically for patients undergoing cataract surgery under local anesthesia. Unlike standard clinical procedures where surgical drapes lay directly on the patient's face and supplemental oxygen is administered via high-velocity nasal tubing, this device acts as a physical barrier. It is positioned over the patient's head to lift the weight of the sterile drapes completely off the mouth and nose area, thereby eliminating drape-induced physical pressure, a sense of confinement, and dyspnea.

Concurrently, the device features a specialized design that allows supplemental oxygen to be delivered directly into the cage micro-environment. This setup eliminates the need for direct nasal cannulas, preventing high-velocity airflow from causing mucosal dryness and subsequent iritative cough reflexes during crucial microscopic surgical steps. This dual-action approach simultaneously addres

Primary outcomes

  1. Changes in Systolic and Diastolic Blood Pressure

    Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)

    Evaluates perioperative and intraoperative hemodynamic stability. Measurements are performed using the cardiac monitoring unit of the anesthesia machine during surgery, and a portable monitor postoperatively.

  2. Changes in Respiratory Rate

    Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room).

    Evaluates perioperative and intraoperative respiratory stability. Measurements are performed using the gas module/monitoring of the anesthesia machine during surgery, and a portable monitor postoperatively.

  3. Changes in Heart Rate

    Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)

    Evaluates perioperative and intraoperative cardiac stability. Measurements are performed using the cardiac monitoring unit of the anesthesia machine during surgery, and a portable monitor postoperatively.

  4. Changes in Oxygen Saturation

    Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)

    Evaluates perioperative and intraoperative peripheral oxygenation levels. Measurements are performed using the pulse oximetry unit of the anesthesia machine during surgery, and a portable monitor postoperatively.

  5. Changes in End-Tidal Carbon Dioxide

    Time frame: Intraoperatively (at the 5th, 10th, 15th, 20th, and 25th minutes of the surgery).

    Evaluates intraoperative ventilation status. Measurements are performed using the gas module of the GE Datex Ohmeda S Avance anesthesia machine. (Note: This parameter is only measured intraoperatively)

  6. Changes in Anxiety Level Evaluated by State-Trait Anxiety Inventory (STAI-S)

    Time frame: Baseline (15 minutes pre-operation) and postoperatively (5 minutes after transfer back to the patient room)

    Evaluates the patient's pre-operative and post-operative situational anxiety levels using the State-Trait Anxiety Inventory (STAI-S). The scale score ranges from 20 to 80, where higher scores indicate higher levels of anxiety.

  7. Changes in Anxiety Level Evaluated by Visual Analog Scale for Anxiety (VAS-A)

    Time frame: Baseline (15 minutes pre-operation), intraoperatively (at the 15th minute of the surgery), and postoperatively (5 minutes after transfer back to the patient room).

    Evaluates the patient's anxiety levels across perioperative, intraoperative, and postoperative phases using the Visual Analog Scale for Anxiety (VAS-A). The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates the worst possible anxiety.

    Preoperative: Baseline measurement in the patient room.

    Intraoperative: Real-time anxiety assessment under the surgical drapes at the 15th minute of cataract surgery without disrupting the sterile field.

    Postoperative: Assessment in the patient room after transfer.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep KAYA PEHLİVAN, Lecturer

CONTACT

[email protected]

05073404051

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Oxygen Support Cage Material Use During Cataract Surgery on Operation Time, Anxiety, Physiological Parameters, and Patient Experiences: A Mixed Methods Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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