Consecutive ExotropiaNCT07848139
Surgical Management of Consecutive Exotropia : Surgical Choice Based on the Angle of Deviation
A study testing patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession in people with Consecutive Exotropia and Medial Rectus Advancement, run by Minia University at 1 site in Egypt.
Trial summary
Aim of the work: to have a surgical plan for consecutive exotropia based on the degree of the angle of deviation. Setting: Department of ophthalmology, Faculty of medicine, Minia University, Egypt. Patients and methods: Study design: retrospective study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Consecutive Exotropia, Medial Rectus Advancement
- What is being tested?
- patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Aug 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with consecutive exotropia following one previous strabismus surgery for esotropia.
Who cannot join
- Patients who have undergone multiple previous strabismus surgeries other than the initial surgery for esotropia.
- Patients with paralytic strabismus, including third cranial nerve palsy. Patients with other causes of exotropia, such as the Helveston triad.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the work: to have a surgical plan for consecutive exotropia based on the degree of the angle of deviation.
Setting: Department of ophthalmology, Faculty of medicine, Minia University, Egypt.
Read more
Patients and methods:
Study design: retrospective study. Study population 30 Patients with consecutive exotropia were retrospectively divided into two groups Group A: patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession Group B :patients with angle of deviation more than 30 PD had undergone medial rectus advancement of one or both eyes, with or without , unilateral or bilateral lateral rectus recession according to the angle of deviation Follow up visits :first day, first week, one month , three months and six months
Inclusion criteria:
Patients with consecutive exotropia (those patients have done one strabismus surgery for esotropia )
Exclusion criteria:
Patients with multiple strabismus surgeries (other than the first surgery for esotropia )
Paralytic strabismus (third nerve palsy )
Other causes of exotropia (eg Helveston triad )
Outcome measures :
Success is defined as postoperative esodeviation less than or equals 10 PD to exodeviation less than or equals 10 PD.
Read the detailed description
Consecutive exotropia is an outward ocular deviation that develops following previous surgical correction of esotropia. It may occur early after surgery or develop gradually over time and can be associated with cosmetic concerns, impaired binocular function, and symptomatic diplopia. The development of consecutive exotropia may be related to several factors, including the degree of previous surgical correction, reduced medial rectus muscle function, mechanical or restrictive changes, and other patient-related factors.
The surgical management of consecutive exotropia remains variable and is generally individualized according to the magnitude of the postoperative deviation, the status of the previously operated medial rectus muscles, and the surgical history. Common surgical approaches include lateral rectus recession, medial rectus advancement, or a combination of medial rectus advancement and lateral rectus recession. However, a practical surgical strategy based primarily on the magnitude of the angle of deviation may facilitate surgical planning in patients with consecutive exotropia following a single previous operation for esotropia.
This retrospective study evaluates a surgical management strategy in which the surgical procedure is selected according to the preoperative angle of consecutive exotropia. Patients with a deviation of 30 prism diopters (PD) or less are managed with bilateral lateral rectus recession. Patients with a deviation greater than 30 PD are managed with advancement of one or both previously recessed medial rectus muscles, with or without unilateral or bilateral lateral rectus recession according to the magnitude of the deviation.
The study will assess postoperative ocular alignment and clinical outcomes following this angle-based surgical approach. Postoperative assessments will be performed at predefined follow-up visits to evaluate the stability of ocular alignment and identify postoperative complications or recurrent deviation.
The primary purpose of the study is to evaluate whether selection of the surgical procedure according to the magnitude of the preoperative angle provides a practical approach for the surgical management of consecutive exotropia. The findings may help characterize the postoperative alignment achieved with the different surgical approaches and provide clinical information regarding the applicability of an angle-based surgical strategy in patients with consecutive exotropia after previous esotropia surgery.
- Conditions
- Consecutive Exotropia, Medial Rectus Advancement
- Being tested
- patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession
- Keywords
- consecutive exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recessionProcedure or surgery
patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession
| Study group | Role | What they receive |
|---|---|---|
| patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession | Other | patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession Receives: Procedure: patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Successful Postoperative Ocular Alignment at 12 Months
Successful postoperative ocular alignment is defined as alignment within 10 prism diopters (PD) of esodeviation to 10 PD of exodeviation, inclusive, at 12 months after surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jun 2023
- Primary completion1 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Consecutive ExotropiaStudies of the same condition, open and under way.
- More trials run by Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ramadan, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848139
- Sponsor's protocol ID
- 1597:07/2023
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donaldson MJ, Forrest MP, Gole GA. The surgical management of consecutive exotropia. J AAPOS. 2004 Jun;8(3):230-6. doi: 10.1016/j.jaapos.2004.01.001.
PubMed 15226722
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Consecutive Exotropia : Surgical Choice Based on the Angle of Deviation
- ClinicalTrials.gov ID
- NCT07848139
- Acronym / sponsor ID
- 1597:07/2023
- Conditions
- Consecutive Exotropia, Medial Rectus Advancement
- Keywords
- consecutive exotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 29 Sep 2026 (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.
Aim of the work: to have a surgical plan for consecutive exotropia based on the degree of the angle of deviation.
Setting: Department of ophthalmology, Faculty of medicine, Minia University, Egypt.
Patients and methods:
Study design: retrospective study. Study population 30 Patients with consecutive exotropia were retrospectively divided into two groups Group A: patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession Group B :patients with angle of deviation more than 30 PD had undergone medial rectus advancement of one or both eyes, with or without , unilateral or bilateral lateral rectus recession according to the angle of deviation Follow up visits :first day, first week, one month , three months and six months
Inclusion criteria:
Patients with consecutive exotropia (those patients have done one strabismus surgery for esotropia )
Exclusion criteria:
Patients with multiple strabismus surgeries (other than the first surgery for esotropia )
Paralytic strabismus (third nerve palsy )
Other causes of exotropia (eg Helveston triad )
Outcome measures :
Success is defined as postoperative esodeviation less than or equals 10 PD to exodeviation less than or equals 10 PD.
Detailed description
Consecutive exotropia is an outward ocular deviation that develops following previous surgical correction of esotropia. It may occur early after surgery or develop gradually over time and can be associated with cosmetic concerns, impaired binocular function, and symptomatic diplopia. The development of consecutive exotropia may be related to several factors, including the degree of previous surgical correction, reduced medial rectus muscle function, mechanical or restrictive changes, and other patient-related factors.
The surgical management of consecutive exotropia remains variable and is generally individualized according to the magnitude of the postoperative deviation, the status of the previously operated medial rectus muscles, and the surgical history. Common surgical approaches include lateral rectus recession, medial rectus advancement, or a combination of medial rectus advancement and lateral rectus recession. However, a practical surgical strategy based primarily on the magnitude of the angle of deviation may facilitate surgical planning in patients with consecutive exotropia following a single previous operation for esotropia.
This retrospective study evaluates a surgical management strategy in which the surgical procedure is selected according to the preoperative angle of consecutive exotropia. Patients with a deviation of 30 prism diopters (PD) or less are managed with bilateral lateral rectus recession. Patients with a deviation greater than 30 PD are managed with advancement of one or both previously recessed medial rectus muscles, with or without unilateral or bilateral lateral rectus recession according to the magnitude of the deviation.
The study will assess postoperative ocular alignment and clinical outcomes following this angle-based surgical approach. Postoperative assessments will be performed at predefined follow-up visits to evaluate the stability of ocular alignment and identify postoperative complications or recurrent deviation.
The primary purpose of the study is to evaluate whether selection of the surgical procedure according to the magnitude of the preoperative angle provides a practical approach for the surgical management of consecutive exotropia. The findings may help characterize the postoperative alignment achieved with the different surgical approaches and provide clinical information regarding the applicability of an angle-based surgical strategy in patients with consecutive exotropia after previous esotropia surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession | Other | Procedure: patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recessionpatients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with consecutive exotropia following one previous strabismus surgery for esotropia.
Key exclusion criteria (3 listed)
- Patients who have undergone multiple previous strabismus surgeries other than the initial surgery for esotropia.
- Patients with paralytic strabismus, including third cranial nerve palsy. Patients with other causes of exotropia, such as the Helveston triad.
- -
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 |
|---|---|---|
| patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recessionpatients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession | Procedure or surgery | patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession |
Primary outcome
Number of Participants with Successful Postoperative Ocular Alignment at 12 Months
Time frame: 1 year
Successful postoperative ocular alignment is defined as alignment within 10 prism diopters (PD) of esodeviation to 10 PD of exodeviation, inclusive, at 12 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Results publication: PubMed 15226722Donaldson MJ, Forrest MP, Gole GA. The surgical management of consecutive exotropia. J AAPOS. 2004 Jun;8(3):230-6. doi: 10.1016/j.jaapos.2004.01.001.
- Individual participant dataSharing planned: No
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?
A study testing patients with angle of deviation of 30 PD or less had undergone bilateral lateral rectus recession in people with Consecutive Exotropia and Medial Rectus Advancement, run by Minia University at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Sep 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Successful Postoperative Ocular Alignment at 12 Months (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07848139, which also lists 1 linked publication.
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 29 Sep 2026.