CataractsNCT01846078
Accuracy of Holladay 2 Formula in the Absence of Lens Thickness
A study testing optical biometric measurement (IOLMaster) in people with Cataracts, run by Mahidol University at 1 site in Thailand.
Trial summary
Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data. Read more about this study
- Who is it for?
- Ages 44 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataracts
- What is being tested?
- optical biometric measurement (IOLMaster)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Dec 2012
- 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 44 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with cataract
Who cannot join
- previous ocular diseases
- previous ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Holladay 2 Formula Using IOLMaster Parameters in the Absence of Lens Thickness
Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.
- Conditions
- Cataracts
- Being tested
- optical biometric measurement (IOLMaster)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical biometric measurement (IOLMaster)Device
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
| Study group | Role | What they receive |
|---|---|---|
| Mean absolute errors, median absolute errors | Experimental | Not described Receives: Device: optical biometric measurement (IOLMaster) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean absolute error of Holladay2 formula
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabong Srivannaboon, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846078
- Sponsor's protocol ID
- Si343/2012
- Status last verified
- Apr 2013
- First submitted
- 30 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
Publications
Narvaez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006 Dec;32(12):2050-3. doi: 10.1016/j.jcrs.2006.09.009.
PubMed 17137982
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Holladay 2 Formula Using IOLMaster Parameters in the Absence of Lens Thickness
- ClinicalTrials.gov ID
- NCT01846078
- Acronym / sponsor ID
- Si343/2012
- Conditions
- Cataracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 May 2013 (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.
Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mean absolute errors, median absolute errors | Experimental | Device: optical biometric measurement (IOLMaster) |
Who may qualify
- Ages
- 44 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cataract
Key exclusion criteria (2 listed)
- previous ocular diseases
- previous ocular surgery
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 |
|---|---|---|
| optical biometric measurement (IOLMaster)IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique. | Device | Mean absolute errors, median absolute errors |
Primary outcome
mean absolute error of Holladay2 formula
Time frame: 6 months
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Background: PubMed 17137982Narvaez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006 Dec;32(12):2050-3. doi: 10.1016/j.jcrs.2006.09.009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optical biometric measurement (IOLMaster) in people with Cataracts, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2013. 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 Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean absolute error of Holladay2 formula (time frame: 6 months). 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 NCT01846078, which also lists 1 linked publication.
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 3 May 2013.