Effects of Oxygen Cage Support During Cataract Surgery

NCT07632326 | Not Yet Recruiting

• 2 other identifiers: ZKP_ATAUNI_001Ataturk Unıversity
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cataract

Keywords

Cataract Surgery; Oxygen Support; Anxiety; Patient Experience; Surgical Nursing

Outcome Measures

Primary Outcomes (7)

• Changes in Systolic and Diastolic Blood Pressure

  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.

  Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).

• Changes in Respiratory Rate

  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.

  Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).

• Changes in Heart Rate

  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.

  Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).

• Changes in Oxygen Saturation

  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.

  Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).

• Changes in End-Tidal Carbon Dioxide

  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)

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

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

  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.

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

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

  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.

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

Study Arms (2)

Oxygen Support Cage Group

EXPERIMENTAL

Participants in this arm will undergo cataract surgery with the integration of a newly developed, 3D-printed, biocompatible Oxygen Support Cage. This medical device is placed over the patient's head to elevate the sterile surgical drapes, preventing them from exerting weight pressure or making direct contact with the patient's face, mouth, and nose. Supplemental oxygen is delivered directly into the cage micro-environment to ensure stable, high-concentration oxygenation. This setup aims to prevent mucosal dryness and irritative cough reflexes while reducing drape-induced anxiety and dyspnea.

Other: Oxygen Support Cage

Control Group: Standard Care

NO INTERVENTION

Participants in this arm will receive the standard hospital protocol for cataract surgery under local anesthesia. Supplemental oxygen will be administered nasally via standard open-ended oxygen tubing placed directly beneath the conventional surgical drapes. No cage support or drape-elevating device will be used; the sterile surgical drapes will rest directly over the patient's face as per routine clinical practice.

Interventions

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

Oxygen Support Cage Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in the study voluntarily and provides informed consent
• Aged 18 years or older
• Having no hearing or cognitive impairments

You may not qualify if:

• Conversion from local anesthesia to general anesthesia during the surgery
• Patient's non-participation or refusal to complete the anxiety assessment during the surgery

Sponsors & Collaborators

• Ataturk University: lead

Related Publications (2)

• Guan GQ, Lin XD, Bao JL, Zhou XZ. Effect of cervical pillow in phacoemulsification surgery for age-related cataract patients: a prospective randomized controlled study. Int Ophthalmol. 2024 Jun 11;44(1):232. doi: 10.1007/s10792-024-03090-0.

  PMID: 38861013 BACKGROUND

• Yenigun SC, Demir Korkmaz F. The Effects of Stress Ball Practice on Patient Anxiety, Pain and Vital Signs During Cataract Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):592-599. doi: 10.1016/j.pmn.2025.04.009. Epub 2025 May 20.

  PMID: 40399154 BACKGROUND

MeSH Terms

Conditions

Cataract; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Mental Disorders

Central Study Contacts

Zeynep KAYA PEHLİVAN, Lecturer

CONTACT

05073404051; z.y.n.p04@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study will be conducted using a mixed-methods design incorporating a randomized controlled experimental design (intervention/control groups) and qualitative methods. Mixed-methods allow the holistic execution of qualitative and quantitative data collection and analysis, addressing the research problem comprehensively. This approach yields stronger, integrated findings compared to single methods. The primary purpose is to enrich the phenomenon through different data types, integrate data by comparison, and increase validity and reliability. A convergent parallel mixed-methods design will be utilized; quantitative and qualitative data will be collected concurrently, analyzed independently, and combined to create a holistic perspective. The phase investigating the effect of using the Oxygen Support Cage during Cataract Surgery on Operation Time, Anxiety, and Physiological Parameters is planned as quantitative research.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share