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CompletedNCT04327856Updated Jul 8, 2020

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

An observational study in Patient Satisfaction, Patient Compliance and Patient Engagement, sponsored by Medical University of Bialystok. Completed at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Medical University of Bialystok · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patient Satisfaction
  • Patient Compliance
  • Patient Engagement

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Keywords

  • cataract surgery
  • quality of life
  • patient satisfaction
  • patient experiences
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 200 is above the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureCataract Surgery

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

06

What researchers measure

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.

    Time frame: 3 hours post operation

07

Study locations

2 sites
  • Medical University
    Białystok, 15-089, Poland
  • Ophthalmology Clinic Medical University of Bialystok
    Białystok, 15-089, Poland
08

References and documents

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. PubMed 19251145 ↗
  • 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. PubMed 12140210 ↗
  • 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. PubMed 9368170 ↗
  • 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. PubMed 33658752 ↗
  • 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. PubMed 33061274 ↗

Individual participant data

Plan to share: Undecided — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04327856
Lead sponsor
Medical University of Bialystok
Responsible party
Sponsor
First posted
Mar 31, 2020
Start date
Feb 15, 2020
Primary completion
Apr 15, 2020
Completion
May 15, 2020
Last update
Jul 8, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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