Bilateral CataractCatquestCBSNCT05069753
Patient Reported Visual Satisfaction Following Same Day or Delayed Bilateral Cataract Surgery
A study testing Immediate sequential bilateral cataract surgery (ISBCS) and Delayed sequential bilateral cataract surgery (DSBCS) in people with Bilateral Cataract and Charles Bonnet Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Cataract, Charles Bonnet Syndrome
- What is being tested?
- Immediate sequential bilateral cataract surgery (ISBCS) and Delayed sequential bilateral cataract surgery (DSBCS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, Capital Region, 2600
About this study
Official title: Patient Reported Visual Function Outcome Following Bilateral Cataract Surgery
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.
Read the 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
- Being tested
- Immediate sequential bilateral cataract surgery (ISBCS), Delayed sequential bilateral cataract surgery (DSBCS)
- Medical subject headings
- Cataract, Charles Bonnet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate sequential bilateral cataract surgery (ISBCS)Procedure or surgery
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)Procedure or surgery
The group will undergo bilateral cataract surgery on two separate days with a time period of one week between the two procedures.
| Study group | Role | What they receive |
|---|---|---|
| Immediate sequential bilateral cataract surgery (ISBCS) | Active comparator | Not described Receives: Procedure: Immediate sequential bilateral cataract surgery (ISBCS) |
| Delayed sequential bilateral cataract surgery (DSBCS) | Active comparator | Not described Receives: Procedure: Delayed sequential bilateral cataract surgery (DSBCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline at the preoperative visit, 1 week post-surgery, and 3 months post-surgery
Secondary outcomes (7)
Objective change in visual acuity
Measured using autorefractor
Measured: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Objective change in refraction status
Measured using autorefractor
Measured: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Intraocular pressure (IOP)
Measured using I-Care Tonometry
Measured: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Complications
Incidence of intraoperative and postoperative complications
Measured: Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS
Presence of corneal edema
Determined during clinical examination using slit lamp
Measured: One week after ISBCS or 2nd eye surgery in DSBCS
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.
Measured: At the preoperative visit
Knowledge of Charles Bonnet Syndrome
Participants will be asked about previous knowledge of hallucinations caused by loss of vision.
Measured: At the preoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Bilateral CataractStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Assenholt Nielsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Amardeep Singh, MD, PhD, Study director, Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of CopenhagenMads Assenholt Nielsen, Principal investigator, Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069753
- Sponsor's protocol ID
- CatQuestCBS
- Acronym
- CatquestCBS
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arshinoff SA, Odorcic S. Same-day sequential cataract surgery. Curr Opin Ophthalmol. 2009 Jan;20(1):3-12. doi: 10.1097/ICU.0b013e32831b6daf.
PubMed 19077823Arshinoff 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.
PubMed 22995967Arshinoff 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.
PubMed 32756782Cetinkaya 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.
PubMed 25336907Coyle 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.
PubMed 10155334Hartney 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.
PubMed 21430494Henderson 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.
PubMed 22995968Herrinton 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.
PubMed 28438415Jones 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.
PubMed 33628948Leivo 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.
PubMed 21596243Lundstrom 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.
PubMed 18786128Lundstrom 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.
PubMed 19251145Morley AM, Murdoch I. The future of glaucoma clinics. Br J Ophthalmol. 2006 May;90(5):640-5. doi: 10.1136/bjo.2005.085522.
PubMed 16622096Niazi 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.
PubMed 31654492Nielsen 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.
PubMed 30242976
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Visual Function Outcome Following Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT05069753
- Acronym / sponsor ID
- CatquestCBS / CatQuestCBS
- Conditions
- Bilateral Cataract, Charles Bonnet Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Immediate sequential bilateral cataract surgery (ISBCS) |
| 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. | Procedure or surgery | Delayed sequential bilateral cataract surgery (DSBCS) |
Primary outcome
Change in patient reported visual function outcome following either ISBCS or DSBCS
Time frame: 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
7 secondary outcomes
Objective change in visual acuity
Time frame: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Objective change in refraction status
Time frame: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Intraocular pressure (IOP)
Time frame: At the preoperative visit and 1 week after ISBCS or 2nd eye surgery in DSBCS
Complications
Time frame: Intraoperatively, one day after surgery and up to one week after ISBCS or 2nd eye surgery in DSBCS
Presence of corneal edema
Time frame: One week after ISBCS or 2nd eye surgery in DSBCS
Presence of Charles Bonnet Syndrome
Time frame: At the preoperative visit
Knowledge of Charles Bonnet Syndrome
Time frame: At the preoperative visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 19077823Arshinoff SA, Odorcic S. Same-day sequential cataract surgery. Curr Opin Ophthalmol. 2009 Jan;20(1):3-12. doi: 10.1097/ICU.0b013e32831b6daf.
- Background: PubMed 22995967Arshinoff 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.
- Background: PubMed 32756782Arshinoff 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.
- Background: PubMed 25336907Cetinkaya 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.
- Background: PubMed 10155334Coyle 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.
- Background: PubMed 21430494Hartney 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.
- Background: PubMed 22995968Henderson 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.
- Background: PubMed 28438415Herrinton 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.
- Background: PubMed 33628948Jones 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.
- Background: PubMed 21596243Leivo 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.
- Background: PubMed 18786128Lundstrom 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.
- Background: PubMed 19251145Lundstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amardeep Singh, MD, PhD study director
Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen
Mads Assenholt Nielsen principal investigator
Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate sequential bilateral cataract surgery (ISBCS) and Delayed sequential bilateral cataract surgery (DSBCS) in people with Bilateral Cataract and Charles Bonnet Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amardeep Singh, MD, PhD (+45 20 93 09 49, a.singh.opth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported visual function outcome following either ISBCS or DSBCS (time frame: Baseline at the preoperative visit, 1 week post-surgery, and 3 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069753, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.