CataractNCT06364761
Assesment of Intermediate Vision After BIL Cataract Surgery
An observational study of Cataract, run by Universitair Ziekenhuis Brussel.
Trial summary
The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Bag in the lens cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent bilateral bag in the lens cataract surgery in the University Hospital Brussels at least 3 months before inclusion
Who may be able to join
- Patients of at least 18 years old
- Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion
- Must not meet any exclusion criteria
Who cannot join
- Prior refractive surgery (other than bag in the lens)
- Glaucoma
- Corneal opacities
- Moderate non proliferative diabetic retinopathy or worse
- Optic neuropathy
- History of uveitis
Show all 10Show fewer
- Amblyopia
- Residual post-operative astigmatism higher than 1.5 Diopters (D)
- Best corrected visual acuity < 1.0
- Patients unable to cooperate or sign the informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assesment of Intermediate and Near Vision After Bag in the Lens Cataract Surgery
The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".
The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.
Read more
Participants will:
- Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)
- Have to fill in 2 questionnaires about visual functioning and spectacle independance
Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .
- Conditions
- Cataract
- Being tested
- Bag in the lens cataract surgery
- Keywords
- bag in lens, Intermediate vision
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag in the lens cataract surgeryProcedure or surgery
Cataract surgery using the Morcher 89A intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Bag in the lens | Patients who underwent bag in the lens cataract surgery at least 3 months before inclusion in the University Hospital Brussels, Belgium. Receives: Procedure: Bag in the lens cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate vision
uncorrected and distance corrected intermediate vision at 66cm in LogMAR
Measured: During the only hospital visit required in the study, between april and december 2024
Secondary outcomes (1)
Near vision
uncorrected and distance corrected intermediate vision at 40cm in LogMAR
Measured: During the only hospital visit required in the study, between april and december 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 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 Universitair Ziekenhuis BrusselThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorgos Koulalis, M.D., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364761
- Sponsor's protocol ID
- 24103_BIL_EDOF
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Intermediate and Near Vision After Bag in the Lens Cataract Surgery
- ClinicalTrials.gov ID
- NCT06364761
- Acronym / sponsor ID
- 24103_BIL_EDOF
- Conditions
- Cataract
- Keywords
- bag in lens, Intermediate vision
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Apr 2024 (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.
The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".
The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.
Participants will:
- Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)
- Have to fill in 2 questionnaires about visual functioning and spectacle independance
Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bag in the lens | – | Procedure: Bag in the lens cataract surgeryPatients who underwent bag in the lens cataract surgery at least 3 months before inclusion in the University Hospital Brussels, Belgium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent bilateral bag in the lens cataract surgery in the University Hospital Brussels at least 3 months before inclusion
Key inclusion criteria (3 listed)
- Patients of at least 18 years old
- Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion
- Must not meet any exclusion criteria
Key exclusion criteria (10 listed)
- Prior refractive surgery (other than bag in the lens)
- Glaucoma
- Corneal opacities
- Moderate non proliferative diabetic retinopathy or worse
- Optic neuropathy
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 |
|---|---|---|
| Bag in the lens cataract surgeryCataract surgery using the Morcher 89A intraocular lens | Procedure or surgery | Bag in the lens |
Primary outcome
Intermediate vision
Time frame: During the only hospital visit required in the study, between april and december 2024
uncorrected and distance corrected intermediate vision at 66cm in LogMAR
1 secondary outcome
Near vision
Time frame: During the only hospital visit required in the study, between april and december 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jorgos Koulalis, M.D. principal investigator
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Universitair Ziekenhuis Brussel.
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 3 inclusion and 10 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jorgos Koulalis, M.D. (+32474045858, jorkoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermediate vision (time frame: During the only hospital visit required in the study, between april and december 2024). 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 15 Apr 2024.