An interventional study of Oxygen Support Cage in Cataract, sponsored by Ataturk University. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care
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.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 70 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
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Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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.
Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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.
Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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.
Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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.
Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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)
Time frame: 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.
Time frame: 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.
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).
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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