CataractNCT01372657
Intraocular Lens (IOL) Calculation Improvement
An observational study of Cataract, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- biometry calculation
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2011to May 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: cataract patients
Who may be able to join
- older 18
- clear cornea
- cataract
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Augenzentrum Bahnhof Basel
Basel, Canton of Basel-City, 4051
About this study
Official title: Intraocular Lens (IOL) Formula Calculation Improvement
Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed.
- Conditions
- Cataract
- Being tested
- biometry calculation
- Keywords
- cataract, refraction, iol, calculation, formula
- Medical subject headings
- Cataract, Intraocular Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biometry calculationOther
| Study group | Role | What they receive |
|---|---|---|
| cataract patients | cataract patients Receives: Other: biometry calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative refraction (Diopters)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: slow recruitment
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.
- 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
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Goldblum, MD, Study director, University Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372657
- Sponsor's protocol ID
- EK 304/10
- Status last verified
- Jan 2015
- First submitted
- 7 Jun 2011
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Lens (IOL) Formula Calculation Improvement
- ClinicalTrials.gov ID
- NCT01372657
- Acronym / sponsor ID
- EK 304/10
- Conditions
- Cataract
- Keywords
- cataract, refraction, iol, calculation, formula
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jun 2011 (estimated)
- 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.
Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cataract patients | – | Other: biometry calculationcataract patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cataract patients
Key inclusion criteria (3 listed)
- older 18
- clear cornea
- cataract
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| biometry calculation | Other | cataract patients |
Primary outcome
postoperative refraction (Diopters)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
Related trials for Cataract
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
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.
David Goldblum, MD study director
University Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 0 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: stopped early, as of the sponsor's last update on 8 Jan 2015. 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 Switzerland. 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?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative refraction (Diopters) (time frame: 2 years). 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 8 Jan 2015.