AmblyopiaPhase 1/2NCT00815581
Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009
A Phase 1/2 study testing photorefraction,cycloautorefraction,cycloretinoscopy in people with Amblyopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new method with some advantages in treatment of this problem. In this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- photorefraction,cycloautorefraction,cycloretinoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- May 2008to not given
- Phase
- Phase 1/2
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Amblyopy
- Children between 1 to 10 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new method with some advantages in treatment of this problem. In this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3 years old.
- Conditions
- Amblyopia
- Being tested
- photorefraction,cycloautorefraction,cycloretinoscopy
- Keywords
- children between 1 to 10 years old, amblyopy
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photorefraction,cycloautorefraction,cycloretinoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| photorefraction | Other | Not described Receives: Device: photorefraction,cycloautorefraction,cycloretinoscopy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies 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
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815581
- Sponsor's protocol ID
- 8728
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009
- ClinicalTrials.gov ID
- NCT00815581
- Acronym / sponsor ID
- 8728
- Conditions
- Amblyopia
- Keywords
- children between 1 to 10 years old, amblyopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- First posted
- 30 Dec 2008 (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.
Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new method with some advantages in treatment of this problem. In this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3 years old.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| photorefraction | Other | Device: photorefraction,cycloautorefraction,cycloretinoscopy |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Amblyopy
- Children between 1 to 10 years old
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 |
|---|---|---|
| photorefraction,cycloautorefraction,cycloretinoscopy | Device | photorefraction |
Primary outcome
Not reported in the source record.
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 8 Apr 2010.
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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 Phase 1/2 study testing photorefraction,cycloautorefraction,cycloretinoscopy in people with Amblyopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 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: finished, as of the sponsor's last update on 8 Apr 2010. 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 Iran. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 Apr 2010.