EsotropiaNCT02404324
Conservative Treatment of Esotropia in Children up to 3 Years Old
A study testing Prescription of spectacles in people with Esotropia, run by National Centre of Ophthalmology named after academician Zarifa Aliyeva.
Trial summary
The objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Esotropia
- What is being tested?
- Prescription of spectacles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Nov 2017
- 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 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Within the age of 3 months to 3 years (inclusive infantile esotropia)
- Patients with constant or periodic esotropia and with revealed angle of deviation 5 degrees or over by Hirschberg test
- Patients with refractive errors (inclusive minor ametropias from 0.5 Dptr)
Who cannot join
- Age above 3 years
- Patients with neurological diseases and paralytic strabismus
About this study
Official title: Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia in Children up to 3 Years Old
The objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old.
Read the detailed description
This investigation includes children with esotropia associated with hyperopia, hypermetropic astigmatism, myopia, myopic astigmatism and minor ametropias. All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dpt to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization were administered to the children. The investigators suggest that this approach will give good results in the treatment of esotropia.
- Conditions
- Esotropia
- Being tested
- Prescription of spectacles
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription of spectaclesOther
All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dptr to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization are administered to the children.
| Study group | Role | What they receive |
|---|---|---|
| spectacles | Experimental | Esotropia is treated by full optical correction (spectacles prescription) in all children with refractive errors. Special attention is paid to astigmatism up to 0.5 Dptr.
Intervention: Prescription of spectacles Receives: Other: Prescription of spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The angle of deviation
The absolute success is defined as restored symmetrical eye position.Qualified success is considered as reduction of the angle of deviation. Patients are examined 24 months later to assess outcome of treatment.
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 posted31 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsotropiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Centre of Ophthalmology named after academician Zarifa Aliyeva
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elmar Kasimov, Professor, Study director, National Centre of Ophthalmology named after academician Zarifa Aliyeva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404324
- Sponsor's protocol ID
- Treatment of Esotropia
- Status last verified
- Mar 2015
- First submitted
- 23 Dec 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia in Children up to 3 Years Old
- ClinicalTrials.gov ID
- NCT02404324
- Acronym / sponsor ID
- Treatment of Esotropia
- Conditions
- Esotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Centre of Ophthalmology named after academician Zarifa AliyevaOther government
- Study start
- Jan 2012
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 31 Mar 2015 (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.
The objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old.
Detailed description
This investigation includes children with esotropia associated with hyperopia, hypermetropic astigmatism, myopia, myopic astigmatism and minor ametropias. All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dpt to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization were administered to the children. The investigators suggest that this approach will give good results in the treatment of esotropia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spectacles | Experimental | Other: Prescription of spectaclesEsotropia is treated by full optical correction (spectacles prescription) in all children with refractive errors. Special attention is paid to astigmatism up to 0.5 Dptr. Intervention: Prescription of spectacles |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Within the age of 3 months to 3 years (inclusive infantile esotropia)
- Patients with constant or periodic esotropia and with revealed angle of deviation 5 degrees or over by Hirschberg test
- Patients with refractive errors (inclusive minor ametropias from 0.5 Dptr)
Key exclusion criteria (2 listed)
- Age above 3 years
- Patients with neurological diseases and paralytic strabismus
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 |
|---|---|---|
| Prescription of spectaclesAll children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dptr to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization are administered to the children. | Other | spectacles |
Primary outcome
The angle of deviation
Time frame: 2 years
The absolute success is defined as restored symmetrical eye position.Qualified success is considered as reduction of the angle of deviation. Patients are examined 24 months later to assess outcome of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- 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.
Elmar Kasimov, Professor study director
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Questions about this trial
What is this clinical trial studying?
A study testing Prescription of spectacles in people with Esotropia, run by National Centre of Ophthalmology named after academician Zarifa Aliyeva.
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 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: status not confirmed, as of the sponsor's last update on 11 Apr 2017. 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?
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?
The angle of deviation (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 11 Apr 2017.