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Not yet recruitingNCT06929130Updated Apr 16, 2025

Refractive and Topographic Changes After Strabismus Surgery

An observational study in Strabismus Surgery, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study summary

Strabismus, characterized by a misalignment of the eyes, is a common condition that can result in functional and cosmetic issues, often affecting vision and binocular coordination. Strabismus surgery aims to correct the alignment by adjusting the extraocular muscles, but while the primary goal of surgery is to restore ocular alignment, refractive changes may occur as a secondary effect (1).

The traditional view of strabismus surgery is that it is more difficult to plan than to perform. Nevertheless, some complications sometimes have some clinical significance and may affect the visual acuity, physical appearance, and future life of the patients (2).

Refractive changes are among the complications of strabismus surgery. This is mostly attributed to the fact that surgical interventions to the extraocular muscles change the vectorial forces transmitted to the cornea via the scleral pathway (3).

Other theories on this subject include postoperative scleral wound healing, edema in the orbit and eyelids, change in ciliary body blood flow, and change in crystalline lens shape and curvature. In addition, if the anterior ciliary arteries are damaged during strabismus surgery, the supply of the anterior segment may be disrupted and changes in parameters may occur accordingly (4).

Also, surface tension changes in adjacent tissues due to changes in muscle tension after surgery may result in changes in corneal and anterior segment measurements (5).

The timing of refractive changes after surgery also varies. Some patients experience changes in their refractive status shortly after surgery, while others may develop these changes months or even years later. This delayed onset can make it more challenging to identify the precise cause of the refractive shift, as it may not always be immediately apparent following the initial surgical correction (6).

Research shows that post-strabismus surgery can result in myopic shifts, especially in patients with esotropia, and hyperopic shifts in exotropia. Astigmatism can also develop due to corneal shape changes. Preexisting refractive errors, age, strabismus type, surgical technique, and surgeon experience also influence post-surgical changes .

To investigate the refractive changes that occur following strabismus surgery, with a focus on identifying the type and timing of refractive shifts (such as myopia, hyperopia, or astigmatism) and their association with the type of strabismus and surgical technique used.

02

Conditions studied

  • Strabismus Surgery

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03

In context

Strabismus

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

This study's planned enrollment of 60 is below the median of 96 across 54 observational studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 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
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients diagnosed with concomitant strabismus requiring surgical correction.

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

  • All patients diagnosed with concomitant strabismus requiring surgical correction.
  • Clear ocular media.

Exclusion criteria

Exclusion Criteria:

  • Patients with significant ocular pathology (e.g., cataracts, glaucoma,posterior segment pathology).
  • Patients who have undergone previous intraocular or strabismus surgeries.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • study group

    patients diagnosed with concomitant strabismus requiring surgical correction

06

What researchers measure

Primary outcomes

  1. refractive error

    spherical equivalent of refractive error (measured in diopters, D) before and after strabismus surgery at different follow-up intervals

    Time frame: 6 month

07

Study locations

No study locations are listed for this record.

08

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

Start is estimated for May 2025; primary completion for May 2026, 12 months later.

Of 26 observational studies under Strabismus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 50. This study's planned 12 months is below that.

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

Registered
Apr 8, 2025
First posted
Apr 16, 2025
StartEst.
May 1, 2025
Primary completionEst.
May 1, 2026
CompletionEst.
Aug 1, 2026
Last update
Apr 16, 2025
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 Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06929130
Lead sponsor
Assiut University
Responsible party
Eman Mohammed Moawad Ahmed (residant doctor, Assiut University) — Principal investigator
First posted
Apr 16, 2025
Start date
May 1, 2025 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Apr 16, 2025

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 not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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