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

NCT04327856 | Completed

• 1 other identifier: 1773
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Patient Satisfaction; Patient Compliance; Patient Engagement

Keywords

cataract surgery; quality of life; patient satisfaction; patient experiences

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cataract surgery group

Patients which were administrated to the Ophthalmology Clinic Medical University of Bialystok due to scheduled cataract removal surgery

Procedure: Cataract Surgery

Interventions

Cataract Surgery PROCEDURE

The cataract will be removed from patient's eye and artificial intraocular lens will be implanted

Cataract surgery group

Eligibility Criteria

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

You may qualify if:

• patient agreement to participate in the study after informing them about the nature of the research

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (2)

Medical University

Bialystok, 15-089, Poland

Location

Ophthalmology Clinic Medical University of Bialystok

Bialystok, 15-089, Poland

Location

Related Publications (5)

• 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.

  PMID: 19251145 BACKGROUND

• 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.

  PMID: 12140210 BACKGROUND

• 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.

  PMID: 9368170 BACKGROUND

• 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.

  PMID: 33658752 DERIVED

• 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.

  PMID: 33061274 DERIVED

MeSH Terms

Conditions

Patient Satisfaction; Patient Compliance; Patient Participation

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: February 15, 2020
• Primary Completion: April 15, 2020
• Study Completion: May 15, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-06

Locations

PL (2)