Patient Reported Visual Satisfaction Following Same Day or Delayed Bilateral Cataract Surgery (CatquestCBS)

October 20, 2021 updated by: Mads Assenholt Nielsen, Rigshospitalet, Denmark

Patient Reported Visual Function Outcome Following Bilateral Cataract Surgery

Cataract is currently the leading cause of visual impairment worldwide with age being the most common cause of lenticular opacification. As cataract surgery is the most commonly performed elective surgery worldwide, forecasts of an increasing number of elderly individuals make it clear that efficient and evidence based models for managing cataract in the future need to be implemented to manage the broadening gap between intervention and available resources.

Bilateral cataract is currently treated using same day separate surgical procedures (immediate sequential bilateral cataract surgery (ISBCS) or on separate days (delayed sequential bilateral cataract surgery (DSBCS). Whether one approach is more ideal than the other is an ongoing debate. There is, however, a clear advantage of same day surgery on resource management.

The primary purpose of this clinical study is to measure the patient reported satisfaction regarding vision in a group of 300 participants following either same day or delayed bilateral cataract surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, patient reported satisfaction in regards to vision is measured using a questionnaire based on the validated Catquest-7SF questionnaire. This is a 7-item self-report scale with both general questions related to difficulties in performing daily activities and satisfaction with vision, as well as questions assessing performance in specific daily activities. Each question has multiple predefined response categories ranging from "very great difficulty" to "no difficulty". One question has response categories ranging from "very dissatisfied" to "very satisfied". All questions have a "can't say"-response category. Each response will be translated to a numerical value used to score the participants.

In addition to the Catquest-7SF, the questionnaire used will also include questions related to satisfaction with the surgical approach (same day or delayed) and experiences with and knowledge of complex visual hallucinations.

The additional questions about complex visual hallucinations are used to measure prevalence and knowledge of Charles Bonnet Syndrome among participants referred to elective cataract surgery.

The study is a prospective, randomized cohort study and will include 300 consecutive patients referred to our department for elective bilateral cataract surgery. Eligible patients who provide consent will be randomly allocated in a group of either same day bilateral surgery or surgery on two days separated by one week. In case of serious surgical complications in the same day group, surgery of the second eye will be postponed and the participant will be placed in a new, separate group.

During a preoperative visit to the department, participants will fill out the questionnaire regarding vision and be subjected to the routine clinical ophthalmic examination which includes biometry and refraction status. One day post-surgery, participants will be contacted by phone regarding their vision. One-week post-surgery, participants will undergo a check-up visit that includes the same examinations as the preoperative visit, except for biometry. Three months post-surgery, participants will once again be contacted by phone or letter and asked to fill out the questionnaire again.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Capital Region
      • Glostrup, Capital Region, Denmark, 2600
        • Department of Ophthalmology, Rigshospitalet-Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients planned for bilateral cataract surgery with monofocal intraocular lens implantation in the bag.
  • Patients who agree to be randomly allocated to either ISBCS or DSBCS

Exclusion Criteria:

  • Patients at risk of intra- og postoperative complications or where delayed visual rehabilitation is expected (e.g. glaucoma, anterior chamber depth 2,3 or less, corneal endothelial dystrophy)
  • Patients with axial lengths < 21 mm or > 27 mm
  • Patients in need of immediate surgery
  • Patients only eligible to one group, e.g. those requiring general anesthesia where ISBCS is the preferred approach
  • Patients unable to read, understand or fill out the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate sequential bilateral cataract surgery (ISBCS)
Procedure: Immediate sequential bilateral cataract surgery (ISBCS)
Surgery on both eyes will be performed on the same day as separate procedures: Once surgery on the first eye is completed, a new sterile procedure on the second eye will commence.
Active Comparator: Delayed sequential bilateral cataract surgery (DSBCS)
Procedure: Delayed sequential bilateral cataract surgery (DSBCS)
The group will undergo bilateral cataract surgery on two separate days with a time period of one week between the two procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient reported visual function outcome following either ISBCS or DSBCS
Time Frame: Baseline at the preoperative visit, 1 week post-surgery, and 3 months post-surgery
Change in participant satisfaction in regards to visual function measured using the Catquest 7-SF questionnaire at the preoperative visit as well as 1 week and 3 months after either ISBCS or 2nd eye surgery in DSBCS
Baseline at the preoperative visit, 1 week post-surgery, and 3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective change in visual acuity
Time Frame: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Measured using autorefractor
At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Objective change in refraction status
Time Frame: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Measured using autorefractor
At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Intraocular pressure (IOP)
Time Frame: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Measured using I-Care Tonometry
At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Complications
Time Frame: Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS
Incidence of intraoperative and postoperative complications
Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS
Presence of corneal edema
Time Frame: One week after ISBCS or 2nd eye surgery in DSBCS
Determined during clinical examination using slit lamp
One week after ISBCS or 2nd eye surgery in DSBCS
Presence of Charles Bonnet Syndrome
Time Frame: At the preoperative visit
Participants will be asked if they have experienced complex, visual hallucinations during the time in which their vision has been affected by cataract. In case of presence of complex visual hallucinations, patients will be further interviewed regarding the characteristics of the hallucinations.
At the preoperative visit
Knowledge of Charles Bonnet Syndrome
Time Frame: At the preoperative visit
Participants will be asked about previous knowledge of hallucinations caused by loss of vision.
At the preoperative visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Amardeep Singh, MD, PhD, Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen
  • Principal Investigator: Mads Assenholt Nielsen, Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CatQuestCBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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