Intermittent ExotropiaNCT03952702
Overminus Lens Therapy in Intermittent
An observational study of Intermittent Exotropia and Myopia Overcorrection, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Intermittent Exotropia, Myopia Overcorrection, Over-minus Therapy
- What is being tested?
- Myopic overcorrection
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Jun 2019
- How long will I take part?
- 4 Years
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses
Who may be able to join
- patients diagnosed with IXT
- prescribed overminus lenses
Who cannot join
- a history of previous surgery, ocular pathology
- convergence insufficiency type IXT
- presence of any type of ocular deviation except IXT
- presence of severe myopia (greater than -5.0 D)
- presence of severe hyperopia (greater than +5.0 D)
- presence of moderate or severe amblyopia
- poor compliance with overminus spectacles
- follow up period of <48 months after intervention.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, 35040
About this study
Official title: The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia
In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.
Read the detailed description
Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.
Materials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (>-5.0 D), severe hyperopia (>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.
- Being tested
- Myopic overcorrection
- Keywords
- Intermittent exotropia, overminus lens therapy, myopic overcorrection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopic overcorrectionProcedure or surgery
Myopic overcorrection
What is being measured
The primary outcome is the main question the study is designed to answer.
The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.
Overminus lenses were prescribed on the treatment of intermittent exotropia as the first choice. To investigate the effect of overminus lenses on treatment, progress in fusional capability of the patients evaluated with Newcastle control score system were investigated.
Measured: 4 years
The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia.
Changes in stereopsis values (arcsec) evaluated with TNO test were observed.
Measured: 4 years
The long-term effect of prescribing overminus lenses on refractive changes.
Refractive data of the patients in terms of dioptri were measured with autorefractometer during the long-term follow-up period to observe presence of any myopic shift.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Demirkilinc Biler, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952702
- Sponsor's protocol ID
- Ege30042919
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT03952702
- Acronym / sponsor ID
- Ege30042919
- Keywords
- Intermittent exotropia, overminus lens therapy, myopic overcorrection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 16 May 2019 (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.
In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.
Detailed description
Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.
Materials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (>-5.0 D), severe hyperopia (>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses
Key inclusion criteria (2 listed)
- patients diagnosed with IXT
- prescribed overminus lenses
Key exclusion criteria (8 listed)
- a history of previous surgery, ocular pathology
- convergence insufficiency type IXT
- presence of any type of ocular deviation except IXT
- presence of severe myopia (greater than -5.0 D)
- presence of severe hyperopia (greater than +5.0 D)
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 |
|---|---|---|
| Myopic overcorrectionMyopic overcorrection | Procedure or surgery | – |
Primary outcome
The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.
Time frame: 4 years
Overminus lenses were prescribed on the treatment of intermittent exotropia as the first choice. To investigate the effect of overminus lenses on treatment, progress in fusional capability of the patients evaluated with Newcastle control score system were investigated.
The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia.
Time frame: 4 years
Changes in stereopsis values (arcsec) evaluated with TNO test were observed.
The long-term effect of prescribing overminus lenses on refractive changes.
Time frame: 4 years
Refractive data of the patients in terms of dioptri were measured with autorefractometer during the long-term follow-up period to observe presence of any myopic shift.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- 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.
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?
An observational study of Intermittent Exotropia and Myopia Overcorrection, run by Ege 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 2 inclusion and 8 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 16 May 2019. 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?
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 long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia. (time frame: 4 years). The study lists 3 primary outcomes in all. 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 16 May 2019.