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Status unknownNCT03952702Updated May 16, 2019

Overminus Lens Therapy in Intermittent

An observational study in Intermittent Exotropia, Myopia Overcorrection and Over-minus Therapy, sponsored by Ege University. Status unknown at 1 site in Turkey. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-05-16.

Sponsored by Ege University · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
3 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Intermittent Exotropia
  • Myopia Overcorrection
  • Over-minus Therapy
  • Myopia Progression

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Keywords

  • Intermittent exotropia
  • overminus lens therapy
  • myopic overcorrection
03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

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Lead sponsor

Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients diagnosed with IXT
  • prescribed overminus lenses

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)
Target follow-up
4 Years
Patient registry
Yes

Interventions

  • ProcedureMyopic overcorrection

    Myopic overcorrection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 years

  2. 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.

    Time frame: 4 years

  3. 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.

    Time frame: 4 years

07

Study locations

1 site
  • Ege University Faculty of Medicine
    Izmir, 35040, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Jan 2019, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2019
First posted
May 16, 2019
StartActual
Jan 1, 2017
Primary completionActual
Jan 1, 2019
CompletionEst.
Jun 1, 2019
Last update
May 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03952702
Lead sponsor
Ege University
Responsible party
Elif Demirkilinc Biler (Assoc. Prof., M.D., Ege University) — Principal investigator
First posted
May 16, 2019
Start date
Jan 1, 2017
Primary completion
Jan 1, 2019
Completion
Jun 1, 2019 (estimated)
Last update
May 16, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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