NCT05069753

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

Patient Reported Visual Function Outcome Following Bilateral Cataract Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bilateral Cataract
• Charles Bonnet Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-10-06
• Last updated: 2021-10-21

Locations

1 site across 1 country: Denmark