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

The Assessment of Types and Intensity of Unpleasant Experiences Pre-, Intra-, and Postoperatively in the Patients Undergoing Cataract Surgery, Using Especially Designed Questionnaire.

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.

Study Overview

• Status: Completed
• Conditions: Patient Engagement; Patient Satisfaction; Patient Compliance
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Medical University
  • Białystok, Poland, 15-089
    • Ophthalmology Clinic Medical University of Bialystok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intensity of unpleasant experiences pre-, intra-, and postoperatively	Assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.	3 hours post operation

Collaborators and Investigators

• Sponsor: Medical University of Bialystok

Publications and helpful links

General Publications

• Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
• Friedman DS, Tielsch JM, Vitale S, Bass EB, Schein OD, Steinberg EP. VF-14 item specific responses in patients undergoing first eye cataract surgery: can the length of the VF-14 be reduced? Br J Ophthalmol. 2002 Aug;86(8):885-91. doi: 10.1136/bjo.86.8.885.
• Lundstrom M, Roos P, Jensen S, Fregell G. Catquest questionnaire for use in cataract surgery care: description, validity, and reliability. J Cataract Refract Surg. 1997 Oct;23(8):1226-36. doi: 10.1016/s0886-3350(97)80321-5.
• Obuchowska I, Lugowska D, Mariak Z, Konopinska J. Subjective Opinions of Patients About Step-by-Step Cataract Surgery Preparation. Clin Ophthalmol. 2021 Feb 24;15:713-721. doi: 10.2147/OPTH.S298876. eCollection 2021.
• Lugowska D, Konopinska J, Mariak Z, Obuchowska I. Comparison of Subjective Preoperative Experiences of Patients Before First- or Second-Eye Cataract Surgeries. Clin Ophthalmol. 2020 Sep 25;14:2883-2889. doi: 10.2147/OPTH.S270196. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2020
• Primary Completion (ACTUAL): April 15, 2020
• Study Completion (ACTUAL): May 15, 2020

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (ACTUAL): March 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; cataract surgery; patient satisfaction; patient experiences
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No