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CompletedNCT05786053PatternUpdated Mar 27, 2023

Correction of V-pattern Strabismus by Graded Recession of Inferior Oblique Muscle .

An interventional study of graded recession of inferior oblique muscle in V Pattern Esotropia and Monocular Exotropia With V Pattern, sponsored by Tanta University. Completed at 2 sites in Egypt. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Oct 2020, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study summary

V pattern strabismus is the commonest of alphabet pattern. Its identification is essential to plan a proper surgical management. Graded recession is a very logical approach to treat inferior oblique overaction (IOOA). The aim Is to evaluate the efficacy of graded recession of inferior oblique muscle for correction of different grades of V pattern.

Read the detailed description

prospective interventional study for forty patients with V pattern strabismus and primary inferior oblique overeaction will be evaluated by prism cover test to assess the grade of IOOA and amplitude of V-pattern. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11-15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA ( more than 15 degree or +3). Simultaneous correction of the horizontal deviation will be performed at the same sitting. Follow up after I week,1 month ,3 month and 6-month.

02

Conditions studied

  • V Pattern Esotropia
  • Monocular Exotropia With V Pattern

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Keywords

  • Vpattern strabismus
  • inferior oblique overaction
  • graded recession
  • Dissociated vertical deviation
03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 82 interventional studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Cases with V pattern strabismus with the age of the patients will be ≥3 years.

Exclusion criteria

Exclusion Criteria:

    • Structural ocular pathology
  • Significant neurodevelopmental delay
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    v pattern exotropia

    v pattern exotropia patients with associated inferior oblique overreaction

    Procedure: graded recession of inferior oblique muscle

  • Active comparator
    Pattern esotropia

    v pattern esotropia patients with inferior oblique overreaction

    Procedure: graded recession of inferior oblique muscle

Interventions

  • Proceduregraded recession of inferior oblique muscle

    . Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

06

What researchers measure

Primary outcomes

  1. orthotropia in primary position with no v pattern esotropia or exotropia.

    by measuring the distant angle of strabismus in primary and upgaze less than 10prism dioptre.

    Time frame: 6 month

Secondary outcomes

  1. No Inferior oblique overaction

    2.No hypertropia in adducted position.Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degreeor +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA ( 15 or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

    Time frame: 6 month

07

Study locations

2 sites
  • Faculty of medicine
    Tanta, El Gharbeya 1333, Egypt
  • Faculty of medicine
    Tanta, ELGharbia 1333, Egypt
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 reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Jan 2022, 15 months.

Of 35 non-industry interventional studies with no phase under Strabismus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's 15 months is below that.

Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 46.

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

Registered
Feb 20, 2023
First posted
Mar 27, 2023
StartActual
Oct 1, 2020
Primary completionActual
Jan 31, 2022
CompletionActual
Jan 1, 2023
Last update
Mar 27, 2023
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 Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05786053
Lead sponsor
Tanta University
Responsible party
Heba Shafik (Assistant professor of ophthalmology, Tanta University) — Principal investigator
First posted
Mar 27, 2023
Start date
Oct 1, 2020
Primary completion
Jan 31, 2022
Completion
Jan 1, 2023
Last update
Mar 27, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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