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

Bilateral Cataract Clinical Trial

— CatquestCBS  

Official title:

Patient Reported Visual Function Outcome Following Bilateral Cataract Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05069753
• Other study ID #: CatQuestCBS
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2021
• Source: Rigshospitalet, Denmark
• Contact: Amardeep Singh, MD, PhD
• Phone: +45 20 93 09 49
• Email: a.singh.opth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Cataract
• Cataract
• Charles Bonnet Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Rigshospitalet-Glostrup	Glostrup	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (26)

Arshinoff SA, Claoué C, Mehta C, Johanssen B, Mota SH. Bilateral Pseudomonas endophthalmitis after immediately sequential bilateral cataract surgery: primum non nocere. Arq Bras Oftalmol. 2020 Aug;83(4):346-349. doi: 10.5935/0004-2749.20200073. Epub 2020 Jul 29. — View Citation

Arshinoff SA, Odorcic S. Same-day sequential cataract surgery. Curr Opin Ophthalmol. 2009 Jan;20(1):3-12. doi: 10.1097/ICU.0b013e32831b6daf. Review. — View Citation

Arshinoff SA. Same-day cataract surgery should be the standard of care for patients with bilateral visually significant cataract. Surv Ophthalmol. 2012 Nov;57(6):574-9. doi: 10.1016/j.survophthal.2012.05.002. Epub 2012 Sep 18. — View Citation

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Denniston AK, Holland GN, Kidess A, Nussenblatt RB, Okada AA, Rosenbaum JT, Dick AD. Heterogeneity of primary outcome measures used in clinical trials of treatments for intermediate, posterior, and panuveitis. Orphanet J Rare Dis. 2015 Aug 19;10:97. doi: 10.1186/s13023-015-0318-6. Review. — View Citation

European Glaucoma Society: Terminology and guidelines for glaucoma, 3rd edn (2008). Savona, Italy: Editrice Dogma S.r.l.

Hartney KE, Catalano G, Catalano MC. Charles Bonnet syndrome: are medications necessary? J Psychiatr Pract. 2011 Mar;17(2):137-41. doi: 10.1097/01.pra.0000396067.87343.fb. Review. — View Citation

Henderson BA, Schneider J. Same-day cataract surgery should not be the standard of care for patients with bilateral visually significant cataract. Surv Ophthalmol. 2012 Nov;57(6):580-3. doi: 10.1016/j.survophthal.2012.05.001. Epub 2012 Sep 18. — View Citation

Herrinton LJ, Liu L, Alexeeff S, Carolan J, Shorstein NH. Immediate Sequential vs. Delayed Sequential Bilateral Cataract Surgery: Retrospective Comparison of Postoperative Visual Outcomes. Ophthalmology. 2017 Aug;124(8):1126-1135. doi: 10.1016/j.ophtha.2017.03.034. Epub 2017 Apr 21. — View Citation

Jones L, Ditzel-Finn L, Potts J, Moosajee M. Exacerbation of visual hallucinations in Charles Bonnet syndrome due to the social implications of COVID-19. BMJ Open Ophthalmol. 2021 Feb 11;6(1):e000670. doi: 10.1136/bmjophth-2020-000670. eCollection 2021. — View Citation

Kessel L, Andresen J, Erngaard D, Flesner P, Tendal B, Hjortdal J. Immediate Sequential Bilateral Cataract Surgery: A Systematic Review and Meta-Analysis. J Ophthalmol. 2015;2015:912481. doi: 10.1155/2015/912481. Epub 2015 Aug 17. Review. — View Citation

Leivo T, Sarikkola AU, Uusitalo RJ, Hellstedt T, Ess SL, Kivelä T. Simultaneous bilateral cataract surgery: economic analysis; Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2. J Cataract Refract Surg. 2011 Jun;37(6):1003-8. doi: 10.1016/j.jcrs.2010.12.050. — View Citation

Lundström M, Albrecht S, Roos P. Immediate versus delayed sequential bilateral cataract surgery: an analysis of costs and patient value. Acta Ophthalmol. 2009 Feb;87(1):33-8. doi: 10.1111/j.1755-3768.2008.01343.x. Epub 2008 Sep 11. — View Citation

Lundström M, Fregell G, Sjöblom A. Vision related daily life problems in patients waiting for a cataract extraction. Br J Ophthalmol. 1994 Aug;78(8):608-11. — View Citation

Lundström 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. — View Citation

Morley AM, Murdoch I. The future of glaucoma clinics. Br J Ophthalmol. 2006 May;90(5):640-5. Review. — View Citation

Niazi S, Krogh Nielsen M, Singh A, Sørensen TL, Subhi Y. Prevalence of Charles Bonnet syndrome in patients with age-related macular degeneration: systematic review and meta-analysis. Acta Ophthalmol. 2020 Mar;98(2):121-131. doi: 10.1111/aos.14287. Epub 2019 Oct 26. — View Citation

Nielsen E, Lundström M, Pesudovs K, Hjortdal J. Validation of Catquest-9SF in Danish: developing a revised form of the Catquest-9SF - the Danish Catquest-7SF. Acta Ophthalmol. 2019 Mar;97(2):173-177. doi: 10.1111/aos.13921. Epub 2018 Sep 21. — View Citation

Singh A, Sørensen TL. Charles Bonnet syndrome improves when treatment is effective in age-related macular degeneration. Br J Ophthalmol. 2011 Feb;95(2):291-2. doi: 10.1136/bjo.2010.179465. Epub 2010 Aug 23. — View Citation

Singh A, Sørensen TL. The prevalence and clinical characteristics of Charles Bonnet Syndrome in Danish patients with neovascular age-related macular degeneration. Acta Ophthalmol. 2012 Aug;90(5):476-80. doi: 10.1111/j.1755-3768.2010.02051.x. Epub 2010 Nov 25. — View Citation

Singh R, Dohlman TH, Sun G. Immediately sequential bilateral cataract surgery: advantages and disadvantages. Curr Opin Ophthalmol. 2017 Jan;28(1):81-86. Review. — View Citation

Smith CS, Nichols J, Riaz KM. Remission of Charles Bonnet syndrome after cataract extraction. Can J Ophthalmol. 2018 Dec;53(6):e221-e222. doi: 10.1016/j.jcjo.2018.01.036. Epub 2018 Apr 2. — View Citation

Subhi Y, Schmidt DC, Bach-Holm D, Kolko M, Singh A. Prevalence of Charles Bonnet syndrome in patients with glaucoma: a systematic review with meta-analyses. Acta Ophthalmol. 2021 Mar;99(2):128-133. doi: 10.1111/aos.14567. Epub 2020 Aug 4. — View Citation

Tatham A, Brookes JL. 'Bilateral same-day cataract surgery should routinely be offered to patients' - no. Eye (Lond). 2012 Aug;26(8):1033-5. doi: 10.1038/eye.2012.92. Epub 2012 May 25. — View Citation

Tuulonen A & Sintonen H. Health economics, cost-effectiveness and glaucoma care. Grehn F & Stamper R (eds) Glaucoma 2006. Berlin: Springer, 123-133

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective change in visual acuity	Measured using autorefractor	At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Secondary	Objective change in refraction status	Measured using autorefractor	At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Secondary	Intraocular pressure (IOP)	Measured using I-Care Tonometry	At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Secondary	Complications	Incidence of intraoperative and postoperative complications	Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS
Secondary	Presence of corneal edema	Determined during clinical examination using slit lamp	One week after ISBCS or 2nd eye surgery in DSBCS
Secondary	Presence of Charles Bonnet Syndrome	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
Secondary	Knowledge of Charles Bonnet Syndrome	Participants will be asked about previous knowledge of hallucinations caused by loss of vision.	At the preoperative visit