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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069753
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
30.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate sequential bilateral cataract surgery (ISBCS)
  • Procedure: Delayed sequential bilateral cataract surgery (DSBCS)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly allocated to one of two groups using a digital coin toss. Thus they will either undergo same day-surgery of both eyes or have the two surgical procedures separated by one week.Participants will be randomly allocated to one of two groups using a digital coin toss. Thus they will either undergo same day-surgery of both eyes or have the two surgical procedures separated by one week.
Masking:
None (Open Label)
Masking Description:
No masking: The patients will be informed of the type of procedure they will undergo.
Primary Purpose:
Health Services Research
Official Title:
Patient Reported Visual Function Outcome Following Bilateral Cataract Surgery
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in patient reported visual function outcome following either ISBCS or DSBCS [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

Secondary Outcome Measures

  1. Objective change in visual acuity [At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS]

    Measured using autorefractor

  2. Objective change in refraction status [At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS]

    Measured using autorefractor

  3. Intraocular pressure (IOP) [At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS]

    Measured using I-Care Tonometry

  4. Complications [Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS]

    Incidence of intraoperative and postoperative complications

  5. Presence of corneal edema [One week after ISBCS or 2nd eye surgery in DSBCS]

    Determined during clinical examination using slit lamp

  6. Presence of Charles Bonnet Syndrome [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.

  7. Knowledge of Charles Bonnet Syndrome [At the preoperative visit]

    Participants will be asked about previous knowledge of hallucinations caused by loss of vision.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, Rigshospitalet-Glostrup Glostrup Capital Region Denmark 2600

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mads Assenholt Nielsen, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05069753
Other Study ID Numbers:
  • CatQuestCBS
First Posted:
Oct 6, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Charles Bonnet Syndrome
Cataract

Study Results

No Results Posted as of Oct 21, 2021