Patient Reported Visual Satisfaction Following Same Day or Delayed Bilateral Cataract Surgery
NCT ID: NCT05069753
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2021-11-01
2022-08-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Immediate sequential bilateral cataract surgery (ISBCS)
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients who agree to be randomly allocated to either ISBCS or DSBCS
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Mads Assenholt Nielsen
Principal Investigator
Principal Investigators
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Amardeep Singh, MD, PhD
Role: STUDY_DIRECTOR
Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen
Mads Assenholt Nielsen
Role: PRINCIPAL_INVESTIGATOR
Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen
Locations
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Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, Capital Region, Denmark
Countries
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Central Contacts
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References
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Arshinoff SA, Odorcic S. Same-day sequential cataract surgery. Curr Opin Ophthalmol. 2009 Jan;20(1):3-12. doi: 10.1097/ICU.0b013e32831b6daf.
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.
Arshinoff SA, Claoue 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. No abstract available.
Cetinkaya S, Dadaci Z, Aksoy H, Acir NO, Yener HI, Kadioglu E. Toxic anterior-segment syndrome (TASS). Clin Ophthalmol. 2014 Oct 9;8:2065-9. doi: 10.2147/OPTH.S71541. eCollection 2014.
Coyle D, Drummond M. The economic burden of glaucoma in the UK. The need for a far-sighted policy. Pharmacoeconomics. 1995 Jun;7(6):484-9. doi: 10.2165/00019053-199507060-00003. No abstract available.
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.
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.
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.
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.
Leivo T, Sarikkola AU, Uusitalo RJ, Hellstedt T, Ess SL, Kivela 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.
Lundstrom 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.
Lundstrom 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.
Morley AM, Murdoch I. The future of glaucoma clinics. Br J Ophthalmol. 2006 May;90(5):640-5. doi: 10.1136/bjo.2005.085522.
Niazi S, Krogh Nielsen M, Singh A, Sorensen 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.
Nielsen E, Lundstrom 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.
Singh R, Dohlman TH, Sun G. Immediately sequential bilateral cataract surgery: advantages and disadvantages. Curr Opin Ophthalmol. 2017 Jan;28(1):81-86. doi: 10.1097/ICU.0000000000000327.
Singh A, Sorensen 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.
Singh A, Sorensen 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. No abstract available.
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. No abstract available.
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.
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. No abstract available.
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.
European Glaucoma Society: Terminology and guidelines for glaucoma, 3rd edn (2008). Savona, Italy: Editrice Dogma S.r.l.
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.
Lundstrom M, Fregell G, Sjoblom A. Vision related daily life problems in patients waiting for a cataract extraction. Br J Ophthalmol. 1994 Aug;78(8):608-11. doi: 10.1136/bjo.78.8.608.
Tuulonen A & Sintonen H. Health economics, cost-effectiveness and glaucoma care. Grehn F & Stamper R (eds) Glaucoma 2006. Berlin: Springer, 123-133
Other Identifiers
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CatQuestCBS
Identifier Type: -
Identifier Source: org_study_id