Astigmatism of Both EyesNCT04432181
Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
An observational study of Astigmatism of Both Eyes and Amblyopia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
the records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Astigmatism of Both Eyes, Amblyopia, Strabismus
- What is being tested?
- ophthalmic examination
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2018to 3 Feb 2020
- How long will I take part?
- 30 Months
- 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 7 to 13 years
- All sexes
- Child
Study population: children age range between 7 and 13 years with ≥1,75 diopter (D) astigmatism were included. Patients with additional ocular and systemic diseases were excluded in this study. Subjects with and without amblyopia composed group 1 and 2, respectively.
Who may be able to join
- astigmatisma ≥1,75 Diopter
Who cannot join
- systemic diseases additional ocular diseases neurological diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Ophthalmology Department
Sakarya, 54000
About this study
Official title: Associated Professor, Director of Strabismus Department
the records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. children were divided into two groups according to the presence of amblyopia and ocular deviations and other parameters were compared between groups.
Read the detailed description
The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D) astigmatism with or without amblyopia.
The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were noted and compared between the groups. Best corrected visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between amblyopic, fellow and non-amblyopic eyes.
- Conditions
- Astigmatism of Both Eyes, Amblyopia, Strabismus
- Being tested
- ophthalmic examination
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmic examinationOther
ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation
| Study group | Role | What they receive |
|---|---|---|
| Group 1, astigmatic patients with amblyopia | astigmatic children with amblyopia Receives: Other: ophthalmic examination | |
| Group 2, astigmatic patients without amblyopia | astigmatic children without amblyopia Receives: Other: ophthalmic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular deviation
ocular deviation measured by alternate prism cover test, prism diopter
Measured: 24 month
Secondary outcomes (1)
convergence
presence of convergence insufficiency at 10 cm far from visual axe.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start4 Sep 2018
- Primary completion1 Feb 2019
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Astigmatism of Both EyesStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Çakır, Sakarya University
- Investigators
- Burcin Cakir, MD, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432181
- Sponsor's protocol ID
- sakarya amblyopia
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Professor, Director of Strabismus Department
- ClinicalTrials.gov ID
- NCT04432181
- Acronym / sponsor ID
- sakarya amblyopia
- Conditions
- Astigmatism of Both Eyes, Amblyopia, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 16 Jun 2020 (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 records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. children were divided into two groups according to the presence of amblyopia and ocular deviations and other parameters were compared between groups.
Detailed description
The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D) astigmatism with or without amblyopia.
The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were noted and compared between the groups. Best corrected visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between amblyopic, fellow and non-amblyopic eyes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, astigmatic patients with amblyopia | – | Other: ophthalmic examinationastigmatic children with amblyopia |
| Group 2, astigmatic patients without amblyopia | – | Other: ophthalmic examinationastigmatic children without amblyopia |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Age groups
- Child
- Study population
- children age range between 7 and 13 years with ≥1,75 diopter (D) astigmatism were included. Patients with additional ocular and systemic diseases were excluded in this study. Subjects with and without amblyopia composed group 1 and 2, respectively.
Key inclusion criteria (1 listed)
- astigmatisma ≥1,75 Diopter
Key exclusion criteria (1 listed)
- systemic diseases additional ocular diseases neurological diseases
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 |
|---|---|---|
| ophthalmic examinationophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation | Other | Group 1, astigmatic patients with amblyopia, Group 2, astigmatic patients without amblyopia |
Primary outcome
ocular deviation
Time frame: 24 month
ocular deviation measured by alternate prism cover test, prism diopter
1 secondary outcome
convergence
Time frame: 24 month
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 17 Jun 2020.
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.
Burcin Cakir, MD principal investigator
Sakarya University
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 Astigmatism of Both Eyes and Amblyopia, run by Sakarya University at 1 site in Turkey (Türkiye).
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 1 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 17 Jun 2020. 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 Turkey (Türkiye). 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?
ocular deviation (time frame: 24 month). 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 17 Jun 2020.