CataractORAPSCANCT05001932
Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery
A study testing Cataract surgery in people with Cataract, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Cataract surgery is the most common eye surgery in the world. If the patient with cataract uses spectacles and both patient and surgeon find it beneficial, it is possible to compensate for the spectacles during surgery and thereby obtain a spectacle-free distance vision or spectacle-free near vision. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Aug 2021to 1 Jun 2024
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral cataract
- Axial length: 20-27 mm
- ACD > 2.3 mm
- Pupil size: ≥ 5.0 mm in dilatation
- Pupil siza: ≥ 2.5 mm in photo topic condition
- Stereoacuity ≤ 480 seconds of arch
Who cannot join
- Former intraocular surgery
- Other eye disease (amblyopia, strabismus, corneal pathology, glaucoma, uveitis, age related maculopathy
- Other retinal diseases
- Risk of weak zonules due to PEX or former trauma
- Astigmatism ≥ 1.0 diopter
- Diabetes
Show all 13Show fewer
- Axial length difference between the two eyes > 0.3 mm
- Dementia
- Lack of cooperation kooperation
- Stereoacuity > 480 seconds of arc
- Complicated cataract surgery or postoperative complications (intraocular infection, retinal detachment, macular edema
- Business driving
- Night driving
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet - Glostrup
Copenhagen, Glostrup, 2600
Anne Guldhammer Skov, MD, +4538634707, anne.guldhammer.skov.01@regionh.dk
About this study
Cataract surgery is the most common eye surgery in the world. If the patient with cataract uses spectacles and both patient and surgeon find it beneficial, it is possible to compensate for the spectacles during surgery and thereby obtain a spectacle-free distance vision or spectacle-free near vision. Becoming spectacle free increases quality of life substantially and is one of the primary wishes in cataract patients. Socioeconomically, spectacle free life is beneficial as it reduces fall tendency in the elderly population. Multifocal lenses warrant the possibility of obtaining a spectacle free vision at near, intermediate and distance. It is also possible to obtain spectacle free distance and near vision or distance and intermediate vision by using traditional artificial monofocal lenses but making one eye spectacle free for distance and the other eye spectacle free for near or intermediate vision. Currently, it is not know which procedure is most beneficial for cataract patients.
In a recent PhD, the investigators developed a method, Aniseikonia Tolerance Range (ATR), that can assess how much refractive change a patient can endure without impairing stereopsis. The results demonstrated large variation in the tolerance of image difference. This method can be a future tool to assess whether a patient can tolerate the refraction that is considered most beneficial to the patient. The knowledge is important as it can help avoid improper lens choice in cataract surgery and thereby avoid stereopsis problems.
Read the detailed description
Background This randomized clinical trial aims to improve visual outcomes in cataract surgery by examining which intraocular lenses (IOL)/operation methods that provide highest patient satisfaction, visual function and spectacle free vision. Furthermore, the tolerance of surgical induced refractive difference (anisometropia) will be examined and a screening method to assess how much anisometropia a patient can endure will be validated. The investigators will examine if the tolerance of anisometropia > 3 diopters is better than previously described and examine if ATR can predict which patients will experience binocular problems if exposed to surgical induced aniseikonia.These results will lead to higher patient satisfaction, better visual outcomes with elimination of patients with mediocre refractive results and visual problems due to anisometropia.
In addition the investigators will examine whether ATR is reproducible by examining the variation in the multiple measurements and in a prospective study the investigators will investigate the inter and intra person reproducibility of ATR.
100 refractive patients with healthy eyes except myopia > 3 diopters and < 6 diopters, who will have a Small Incision Lenticule Extraction (SMILE) surgery will have all investigations done. The patients will have a bilateral SMILE with a interval of seven weeks and will in between the two procedures have a surgically introduced anisometropia that will provide further knowledge on anisometropia and ATR.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Cataract, Anisometropia, Aniseikonia Tolerance Range
- Medical subject headings
- Cataract, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Randomized Clinical Trial
| Study group | Role | What they receive |
|---|---|---|
| Multifocal | Active comparator | Patients will receive a multifocal lens bilateral (Alcon Vivity). Receives: Procedure: Cataract surgery |
| Mono-vision | Active comparator | Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant myopia of -2.50D. Receives: Procedure: Cataract surgery |
| Minimono-vision | Active comparator | Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant -1.25D. Receives: Procedure: Cataract surgery |
| Monofocal | Active comparator | Patients will receive a monofocal lens bilateral. Target refraction will be -0.25D. Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Investigate if MIOLs, mono-vision and mini-vision provides better visual function, quality of vision and spectacle free vision compared to monofocal IOLs. This will be evaluated by questionnaires and objective measurements as described.
Measured: 120 days
Secondary outcomes (4)
Tolerance of anisometropia
Investigate if the tolerance of anisometropia is better in the elderly population compared to a younger population (SMILE patients). This will be evaluated by questionnaires and objective measurements as described.
Measured: 120 days
Aniseikonia tolerance range (ATR)
Compare ATR in all four arms and in a SMILE population to investigate if ATR is a future screening tool that can predict which patients cannot tolerate anisometropia
Measured: 120 days
Aniseikonia tolerance range (ATR)
Investigate if ATR is reproducible and clinical useful in cataract patients with poor vision
Measured: 120 days
Anisometropia
Investigate if anisometropia > 3 diopters are better tolerated than previously described. This will be evaluated by questionnaires and objective measurements as described.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start11 Aug 2021
- Primary completion4 Aug 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Guldhammer Skov, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Morten la Cour, MD, prof., Study director, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001932
- Sponsor's protocol ID
- H 18058722
- Acronym
- ORAPSCA
- Status last verified
- Oct 2021
- First submitted
- 3 Aug 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery
- ClinicalTrials.gov ID
- NCT05001932
- Acronym / sponsor ID
- ORAPSCA / H 18058722
- Conditions
- Cataract
- Keywords
- Cataract, Anisometropia, Aniseikonia Tolerance Range
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 4 Aug 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 Aug 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 surgery is the most common eye surgery in the world. If the patient with cataract uses spectacles and both patient and surgeon find it beneficial, it is possible to compensate for the spectacles during surgery and thereby obtain a spectacle-free distance vision or spectacle-free near vision. Becoming spectacle free increases quality of life substantially and is one of the primary wishes in cataract patients. Socioeconomically, spectacle free life is beneficial as it reduces fall tendency in the elderly population. Multifocal lenses warrant the possibility of obtaining a spectacle free vision at near, intermediate and distance. It is also possible to obtain spectacle free distance and near vision or distance and intermediate vision by using traditional artificial monofocal lenses but making one eye spectacle free for distance and the other eye spectacle free for near or intermediate vision. Currently, it is not know which procedure is most beneficial for cataract patients.
In a recent PhD, the investigators developed a method, Aniseikonia Tolerance Range (ATR), that can assess how much refractive change a patient can endure without impairing stereopsis. The results demonstrated large variation in the tolerance of image difference. This method can be a future tool to assess whether a patient can tolerate the refraction that is considered most beneficial to the patient. The knowledge is important as it can help avoid improper lens choice in cataract surgery and thereby avoid stereopsis problems.
Detailed description
Background This randomized clinical trial aims to improve visual outcomes in cataract surgery by examining which intraocular lenses (IOL)/operation methods that provide highest patient satisfaction, visual function and spectacle free vision. Furthermore, the tolerance of surgical induced refractive difference (anisometropia) will be examined and a screening method to assess how much anisometropia a patient can endure will be validated. The investigators will examine if the tolerance of anisometropia > 3 diopters is better than previously described and examine if ATR can predict which patients will experience binocular problems if exposed to surgical induced aniseikonia.These results will lead to higher patient satisfaction, better visual outcomes with elimination of patients with mediocre refractive results and visual problems due to anisometropia.
In addition the investigators will examine whether ATR is reproducible by examining the variation in the multiple measurements and in a prospective study the investigators will investigate the inter and intra person reproducibility of ATR.
100 refractive patients with healthy eyes except myopia > 3 diopters and < 6 diopters, who will have a Small Incision Lenticule Extraction (SMILE) surgery will have all investigations done. The patients will have a bilateral SMILE with a interval of seven weeks and will in between the two procedures have a surgically introduced anisometropia that will provide further knowledge on anisometropia and ATR.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multifocal | Active comparator | Procedure: Cataract surgeryPatients will receive a multifocal lens bilateral (Alcon Vivity). |
| Mono-vision | Active comparator | Procedure: Cataract surgeryPatients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant myopia of -2.50D. |
| Minimono-vision | Active comparator | Procedure: Cataract surgeryPatients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant -1.25D. |
| Monofocal | Active comparator | Procedure: Cataract surgeryPatients will receive a monofocal lens bilateral. Target refraction will be -0.25D. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Bilateral cataract
- Axial length: 20-27 mm
- ACD > 2.3 mm
- Pupil size: ≥ 5.0 mm in dilatation
- Pupil siza: ≥ 2.5 mm in photo topic condition
Key exclusion criteria (13 listed)
- Former intraocular surgery
- Other eye disease (amblyopia, strabismus, corneal pathology, glaucoma, uveitis, age related maculopathy
- Other retinal diseases
- Risk of weak zonules due to PEX or former trauma
- Astigmatism ≥ 1.0 diopter
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 |
|---|---|---|
| Cataract surgeryRandomized Clinical Trial | Procedure or surgery | Minimono-vision, Mono-vision, Monofocal, Multifocal |
Primary outcome
Patient satisfaction
Time frame: 120 days
Investigate if MIOLs, mono-vision and mini-vision provides better visual function, quality of vision and spectacle free vision compared to monofocal IOLs. This will be evaluated by questionnaires and objective measurements as described.
4 secondary outcomes
Tolerance of anisometropia
Time frame: 120 days
Aniseikonia tolerance range (ATR)
Time frame: 120 days
Aniseikonia tolerance range (ATR)
Time frame: 120 days
Anisometropia
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- 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.
Morten la Cour, MD, prof. study director
Glostrup University Hospital, 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 Cataract surgery in people with Cataract, 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 6 inclusion and 13 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 1 Nov 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 Anne Guldhammer Skov, MD (+45 38 63 38 63, anne.guldhammer.skov.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2021.