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

NCT05069753 | Unknown

• 1 other identifier: CatQuestCBS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Bilateral Cataract; Charles Bonnet Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in patient reported visual function outcome following either ISBCS or DSBCS

  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 Outcomes (7)

• Objective change in visual acuity

  At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS

• Objective change in refraction status

  At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS

• Intraocular pressure (IOP)

  At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS

• Complications

  Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS

• Presence of corneal edema

  One week after ISBCS or 2nd eye surgery in DSBCS

Study Arms (2)

Immediate sequential bilateral cataract surgery (ISBCS)

ACTIVE COMPARATOR

Procedure: Immediate sequential bilateral cataract surgery (ISBCS)

Delayed sequential bilateral cataract surgery (DSBCS)

ACTIVE COMPARATOR

Procedure: Delayed sequential bilateral cataract surgery (DSBCS)

Interventions

Immediate sequential bilateral cataract surgery (ISBCS) PROCEDURE

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.

Immediate sequential bilateral cataract surgery (ISBCS)

Delayed sequential bilateral cataract surgery (DSBCS) PROCEDURE

The group will undergo bilateral cataract surgery on two separate days with a time period of one week between the two procedures.

Delayed sequential bilateral cataract surgery (DSBCS)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Related Publications (26)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Cataract; Charles Bonnet Syndrome

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Hallucinations; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amardeep Singh, MD, PhD

  Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen

  STUDY DIRECTOR

• Mads Assenholt Nielsen

  Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amardeep Singh, MD, PhD

CONTACT

+45 20 93 09 49; a.singh.opth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking: The patients will be informed of the type of procedure they will undergo.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 6, 2021
• Study Start: November 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)