Strabismus SurgeryNCT06929130
Refractive and Topographic Changes After Strabismus Surgery
An observational study of Strabismus Surgery, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strabismus Surgery
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed with concomitant strabismus requiring surgical correction.
Who may be able to join
- All patients diagnosed with concomitant strabismus requiring surgical correction.
- Clear ocular media.
Who cannot join
- Patients with significant ocular pathology (e.g., cataracts, glaucoma,posterior segment pathology).
- Patients who have undergone previous intraocular or strabismus surgeries.
About this study
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).
Read more
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.
- Conditions
- Strabismus Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients diagnosed with concomitant strabismus requiring surgical correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
refractive error
spherical equivalent of refractive error (measured in diopters, D) before and after strabismus surgery at different follow-up intervals
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strabismus SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Moawad Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929130
- Sponsor's protocol ID
- Ref&TopgraphStrabismus Surg
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive and Topographic Changes After Strabismus Surgery
- ClinicalTrials.gov ID
- NCT06929130
- Acronym / sponsor ID
- Ref&TopgraphStrabismus Surg
- Conditions
- Strabismus Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Apr 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients diagnosed with concomitant strabismus requiring surgical correction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with concomitant strabismus requiring surgical correction.
Key inclusion criteria (2 listed)
- All patients diagnosed with concomitant strabismus requiring surgical correction.
- Clear ocular media.
Key exclusion criteria (2 listed)
- Patients with significant ocular pathology (e.g., cataracts, glaucoma,posterior segment pathology).
- Patients who have undergone previous intraocular or strabismus surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
refractive error
Time frame: 6 month
spherical equivalent of refractive error (measured in diopters, D) before and after strabismus surgery at different follow-up intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
Related trials for Strabismus Surgery
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
Active, not recruiting
Effect of Different Drugs on Emergency Delirium in Preschool Age Patient
Emergence Delirium, Anesthesia
Recruiting
True Muscle Transplantation Surgery Versus Augmented Semi Hang Back Recession in Large Angle Exotropia: Evaluation of Efficacy and Lateral Gaze Incomitance
Large Angle Exotropia
Not yet recruitingObservational study
Japanese Strabismus Outcomes Assessment and Research Group Study
Strabismus
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Strabismus Surgery, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
refractive error (time frame: 6 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 16 Apr 2025.