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The Subjective Pre-, Intra-, and Postoperatively Experiences of Patients Undergoing Cataract Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327856
Recruitment Status : Completed
First Posted : March 31, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

Brief Summary:

Assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.

Strategic aim: formulation of algorithm and modification of perioperative approach to patient qualified to undergo phacoemulsification procedure.


Condition or disease Intervention/treatment
Patient Satisfaction Patient Compliance Patient Engagement Procedure: Cataract Surgery

Detailed Description:

Untreated cataract - the most common reason for an operation in the world - leads to continual decrease in vision, eventually may be the cause of blindness. This condition always requires surgical intervention that involves phacoemulsification with intraocular lens implantation. The procedure takes short amount of time and is performed using topical anaesthesia. Phacoemulsification can be characterised as highly efficient and safe. Besides that, it is still not free from burdens to the patient: causing increased stress levels and anxiety, discomfort or pain, and other symptoms, as surgery is performed on fully conscious and alert patients. Despite, there's lots of research concentrating on patient's quality of life, with different health conditions, the subject of patient's experiences during cataract surgery hasn't been yet fully investigated and explored.

The aim of the study will be an assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.

Strategic aim: formulation of algorithm and modification of perioperative approach to patient qualified to undergo phacoemulsification procedure.

The prospective questionnaire data will be collected for 200 adults: women and men, that were qualified for cataract surgery in Ophthalmology Department of the Białystok University Clinical Hospital, as an elective surgery with patients being qualified based on specific qualifying criteria.

Based on the questionnaire, that have 128 detailed questions, sociodemographic characteristic of patients will be created, and they will be divided into two groups (I and II) depending whether they are undergoing first or second eye surgery. Juxtaposition of different patients experiences and sensations, with their sociodemographic characteristics, as an implication, will lead to identification of factors that cause surgical procedure to be described either as positive or negative experience. The questionnaire is facilitated also selection of the most significant and frequent reasons for dissatisfaction.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Assessment of Types and Intensity of Unpleasant Experiences Pre-, Intra-, and Postoperatively in the Patients Undergoing Cataract Surgery, Using Especially Designed Questionnaire.
Actual Study Start Date : February 15, 2020
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Cataract surgery group
Patients which were administrated to the Ophthalmology Clinic Medical University of Bialystok due to scheduled cataract removal surgery
Procedure: Cataract Surgery
The cataract will be removed from patient's eye and artificial intraocular lens will be implanted




Primary Outcome Measures :
  1. The intensity of unpleasant experiences pre-, intra-, and postoperatively [ Time Frame: 3 hours post operation ]
    Assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the minimum age of 18, qualified for a routine cataract surgery in Ophthalmology Clinic Medical Univesristy of Bialystok, without any coexisting conditions that might complicate cataract suregery. They were patients of various ages and general health, undergoing first or second cataract surgery.
Criteria

Inclusion Criteria:

  • The criteria for inclusion required non complicated cataracts (NC1, NC2) according to The Lens Opacities Classification System III (LOCS III scale). Additional inclusion criteria were as follows: documented progression of best corrected visual acuity less than 0.6 according to Snellen notification
  • patient agreement to participate in the study after informing them about the nature of the research

Exclusion Criteria:

  • bilateral deafness that prevented any communication with the patient;
  • no logical contact with the patient (mental disorders, senile dementia, etc.);
  • any conditions that might complicate the surgery: post-inflammatory or post-traumatic cataract, chronic corneal disease and corneal opacity that prevent intraoperative vision, advanced disease macular degenerative, active inflammatory process, pregnancy, general steroid therapy.
  • lack of patient consent to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327856


Locations
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Poland
Medical University
Białystok, Poland, 15-089
Ophthalmology Clinic Medical University of Bialystok
Białystok, Poland, 15-089
Sponsors and Collaborators
Medical University of Bialystok
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT04327856    
Other Study ID Numbers: 1773
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participants data may be share except any personal details that can enable to make identifiable people who take part in the research i.e. names, surnames, personal identical number

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
cataract surgery
quality of life
patient satisfaction
patient experiences
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases