Primary ExotropiaNCT07637253
Accommodative Changes After Medial Rectus Resection Versus Plication in Primary Exotropia
A study testing Lateral Rectus Recession combined with Medial Rectus Resection and Lateral Rectus Recession combined with Medial Rectus Plication in people with Primary Exotropia and Strabismus, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Exotropia is a type of eye misalignment in which one eye turns outward. In some patients, surgery is needed to improve eye alignment and binocular function. Different surgical techniques can be used to strengthen or adjust the eye muscles responsible for eye position. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Primary Exotropia, Strabismus, Strabismus Surgery
- What is being tested?
- Lateral Rectus Recession combined with Medial Rectus Resection and Lateral Rectus Recession combined with Medial Rectus Plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 15 Aug 2025
- 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 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 5 to 40 years.
- Diagnosis of basic primary exotropia.
- Stable deviation angle over three consecutive preoperative visits.
- Deviation angle of at least 20 prism diopters.
- Literacy and cooperation sufficient to perform accommodative amplitude testing.
- Patients who agreed to undergo unilateral horizontal strabismus surgery.
- Written informed consent obtained from the participant and/or legal guardian.
Who cannot join
- Spherical refractive error greater than ±5.00 diopters.
- Cylindrical refractive error greater than ±3.50 diopters.
- Best-corrected visual acuity worse than 0.1 logMAR.
- Paralytic or restrictive strabismus.
- Previous strabismus surgery.
- Presence of additional ocular pathology, including glaucoma, cataract, uveitis, scleritis, retinal disease, macular disease, or optic neuropathy.
Show all 14Show fewer
- History of ocular trauma.
- Axial length greater than 26.5 mm.
- Aphakia or pseudophakia.
- High accommodative convergence/accommodation ratio.
- Presence of systemic disease.
- Use of medications known to affect accommodation, including topical pilocarpine, cycloplegics, tricyclic antidepressants, or anticholinergic agents.
- Incomplete ophthalmologic or accommodative examinations.
- Loss to follow-up.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Basaksehir Cam and Sakura City Hospital
Istanbul, Basaksehir, 34490
About this study
Official title: Comparison of Surgical Outcomes and Accommodative Changes in Patients With Primary Exotropia Undergoing Medial Rectus Resection-Lateral Rectus Recession and Medial Rectus Plication-Lateral Rectus Recession
Exotropia is a type of eye misalignment in which one eye turns outward. In some patients, surgery is needed to improve eye alignment and binocular function. Different surgical techniques can be used to strengthen or adjust the eye muscles responsible for eye position.
This study compares two surgical approaches used in patients with primary exotropia. In one group, patients undergo medial rectus resection together with lateral rectus recession. In the other group, patients undergo medial rectus plication together with lateral rectus recession. Both procedures aim to improve ocular alignment, but they may differ in their effects on focusing ability, also called accommodation.
Read more
Before surgery, patients undergo a detailed ophthalmologic and strabismus examination, including measurement of ocular deviation and assessment of accommodative function. After surgery, patients are followed and reassessed to evaluate changes in eye alignment, surgical success, and accommodative parameters.
The purpose of this study is to evaluate and compare postoperative eye alignment, surgical success, and changes in accommodative function after these two surgical techniques. The study will help determine whether medial rectus plication and medial rectus resection have different effects on accommodation and surgical outcomes in patients treated for primary exotropia.
Read the detailed description
Primary exotropia is a common form of horizontal strabismus characterized by outward deviation of one eye. Surgical treatment is considered in patients with clinically significant deviation, stable ocular misalignment, symptoms, cosmetic concerns, or impaired binocular function. Horizontal strabismus surgery commonly includes weakening of the lateral rectus muscle, strengthening of the medial rectus muscle, or a combination of both procedures, depending on the measured deviation angle and clinical characteristics of the patient.
Medial rectus resection and medial rectus plication are two medial rectus strengthening techniques used in the surgical management of exotropia. Medial rectus resection involves disinsertion of the medial rectus muscle, removal of a measured segment of the muscle, and reattachment of the shortened muscle to the sclera. Medial rectus plication strengthens the medial rectus muscle by folding and suturing the muscle without complete disinsertion from its original scleral insertion. Because plication avoids full muscle disinsertion and may better preserve the anterior ciliary vessels and adjacent neurovascular structures, it has been proposed as a vessel-sparing and tissue-sparing alternative to resection.
The anterior ciliary arteries travel with the rectus muscles and contribute to the blood supply of the anterior segment, including structures related to accommodation such as the ciliary body and ciliary muscle. Accommodation is the focusing ability of the eye, especially important for near vision. Changes in extraocular muscle tension, ocular alignment, convergence, binocular interaction, and postoperative sensory adaptation may potentially influence accommodative parameters after strabismus surgery. Although the primary goal of exotropia surgery is improvement of ocular alignment, postoperative changes in accommodation may also affect visual comfort, near work, and binocular visual performance. Therefore, evaluation of accommodative changes may provide additional clinically meaningful information beyond motor alignment alone.
This prospective, interventional, comparative clinical study evaluates postoperative surgical outcomes and accommodative changes in patients with primary exotropia who underwent unilateral horizontal strabismus surgery.
Patients aged 5 to 40 years with basic primary exotropia were evaluated for eligibility. Eligible participants had literacy sufficient for accommodative testing, a stable deviation angle over three consecutive preoperative visits, and agreed to undergo unilateral surgery. Surgery was recommended for patients with a deviation angle of at least 20 prism diopters and a stable deviation angle over the last three visits. Patients were excluded if they had high refractive error, reduced best-corrected visual acuity, paralytic or restrictive strabismus, previous strabismus surgery, additional ocular disease, history of ocular trauma, long axial length, aphakia or pseudophakia, high accommodative convergence/accommodation ratio, systemic disease, or use of medications known to affect accommodation. Patients with incomplete examinations or loss to follow-up were excluded from the final analysis.
Participants were assigned to one of two parallel surgical groups according to an alternating sequential allocation method based on enrollment order. The first participant who consented to participate was assigned to the lateral rectus recession plus medial rectus resection group, and the second participant was assigned to the lateral rectus recession plus medial rectus plication group. Subsequent participants were assigned alternately thereafter. No randomization procedure was used.
Participants were assigned to one of two parallel surgical groups according to an alternating sequential allocation method based on enrollment order. The first participant who consented to participate was assigned to the lateral rectus recession plus medial rectus resection group, and the second participant was assigned to the lateral rectus recession plus medial rectus plication group. Subsequent participants were assigned alternately thereafter. No randomization procedure was used. The final analysis included 85 patients: 40 patients in the lateral rectus recession plus medial rectus resection group and 45 patients in the lateral rectus recession plus medial rectus plication group.
The primary functional assessment was accommodative amplitude. Accommodative amplitude was measured separately in each eye using the minus lens method by a single investigator. The highest minus lens power at which clear near vision was maintained was recorded, and 3.00 diopters were added to account for the 33-cm testing distance.
All surgeries were performed under general anesthesia by a single experienced strabismus surgeon. Participants underwent unilateral lateral rectus recession combined with either medial rectus resection or medial rectus plication according to group assignment.
Follow-up examinations were performed at postoperative week 1, postoperative month 1, and postoperative month 3. At each postoperative visit, best-corrected visual acuity, ocular motility, primary position deviation angle, and accommodative amplitude measurements were recorded. Postoperative accommodative changes were evaluated in both the operated and fellow eyes. Changes in accommodative amplitude from baseline to postoperative visits and between postoperative time points were compared within and between the surgical groups.
Surgical outcome was assessed using postoperative ocular alignment. Surgical success at postoperative month 3 was defined as a deviation in the primary position of 10 prism diopters or less of exotropia or 5 prism diopters or less of esotropia. Patients with residual exotropia of 12 prism diopters or more at postoperative month 3 were scheduled for additional surgery in the fellow eye after completion of the study follow-up period.
The main objective of the study is to compare postoperative accommodative changes after lateral rectus recession combined with medial rectus resection versus lateral rectus recession combined with medial rectus plication in patients with primary exotropia. Secondary objectives include comparison of postoperative ocular alignment, surgical success, and time-dependent changes in accommodative amplitude between the two surgical techniques.
By evaluating both motor alignment and accommodative outcomes, this study aims to clarify whether medial rectus plication and medial rectus resection provide comparable surgical correction and whether preservation of anterior segment vascular and neural structures during plication may be associated with different early postoperative accommodative changes.
- Conditions
- Primary Exotropia, Strabismus, Strabismus Surgery, Exotropia, Accomodation
- Being tested
- Lateral Rectus Recession combined with Medial Rectus Resection, Lateral Rectus Recession combined with Medial Rectus Plication
- Keywords
- accomodative amplitude, primary exotropia, exotropia, strabismus surgery, plication, resection
- Medical subject headings
- Exotropia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Rectus Recession combined with Medial Rectus ResectionProcedure or surgery
Unilateral horizontal strabismus surgery consisting of lateral rectus recession combined with medial rectus resection was performed for the treatment of primary exotropia. The lateral rectus muscle was weakened by recession, and the medial rectus muscle was strengthened by resection. In the resection procedure, the medial rectus muscle was isolated, disinserted, shortened by removing a measured segment according to the planned surgical dosage, and reattached to the sclera. Surgical dosage was determined according to the preoperative distance deviation angle. The procedure was performed under general anesthesia by an experienced strabismus surgeon.
Lateral Rectus Recession combined with Medial Rectus PlicationProcedure or surgery
Unilateral horizontal strabismus surgery consisting of lateral rectus recession combined with medial rectus plication was performed for the treatment of primary exotropia. The lateral rectus muscle was weakened by recession, and the medial rectus muscle was strengthened by plication. In the plication procedure, the medial rectus muscle was folded and sutured to strengthen the muscle without complete disinsertion from its original scleral insertion. Surgical dosage was determined according to the preoperative distance deviation angle. The procedure was performed under general anesthesia by an experienced strabismus surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Resection Group | Active comparator | Participants in this arm underwent unilateral lateral rectus recession combined with medial rectus resection for the treatment of primary exotropia. Surgical dosage was planned according to the preoperative distance deviation angle. Postoperative follow-up examinations were performed at week 1, month 1, and month 3 to evaluate ocular alignment, surgical success, and accommodative amplitude. Receives: Procedure: Lateral Rectus Recession combined with Medial Rectus Resection |
| Plication Group | Active comparator | Participants in this arm underwent unilateral lateral rectus recession combined with medial rectus plication for the treatment of primary exotropia. Surgical dosage was planned according to the preoperative distance deviation angle. Postoperative follow-up examinations were performed at week 1, month 1, and month 3 to evaluate ocular alignment, surgical success, and accommodative amplitude. Receives: Procedure: Lateral Rectus Recession combined with Medial Rectus Plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Accommodative Amplitude
Accommodative amplitude was measured separately in each eye using the minus lens method. Measurements were performed before surgery and during postoperative follow-up. The change in accommodative amplitude was calculated by comparing postoperative values with the baseline preoperative value. Measurements were recorded in diopters.
Measured: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3
Secondary outcomes (2)
Ocular Alignment
Ocular alignment was assessed by measuring the angle of deviation in the primary position using the prism and alternate cover test. Distance and near deviation angles were measured before surgery and during postoperative follow-up. Deviation angles were recorded in prism diopters.
Measured: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3
Surgical Success
Surgical success was assessed at postoperative month 3. Success was defined as ocular deviation in the primary position of 10 prism diopters or less of exotropia or 5 prism diopters or less of esotropia.
Measured: Postoperative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start18 Jan 2024
- Primary completion20 Jun 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ExotropiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with primary exotropia were assigned to one of two parallel surgical groups: medial rectus resection combined with lateral rectus recession or medial rectus plication combined with lateral rectus recession. Surgical outcomes and postoperative accommodative changes were compared between the groups. Participants were allocated sequentially to two parallel surgical groups in alternating order according to enrollment sequence. No randomization procedure was used.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Idıl Celen, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637253
- Sponsor's protocol ID
- E-96317027-514.10-236883503
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no specific data-sharing plan was included in the study protocol or informed consent documents. Deidentified aggregate data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Outcomes and Accommodative Changes in Patients With Primary Exotropia Undergoing Medial Rectus Resection-Lateral Rectus Recession and Medial Rectus Plication-Lateral Rectus Recession
- ClinicalTrials.gov ID
- NCT07637253
- Acronym / sponsor ID
- E-96317027-514.10-236883503
- Conditions
- Primary Exotropia, Strabismus, Strabismus Surgery, Exotropia, Accomodation
- Keywords
- accomodative amplitude, primary exotropia, exotropia, strabismus surgery, plication, resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 9 Jun 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.
Exotropia is a type of eye misalignment in which one eye turns outward. In some patients, surgery is needed to improve eye alignment and binocular function. Different surgical techniques can be used to strengthen or adjust the eye muscles responsible for eye position.
This study compares two surgical approaches used in patients with primary exotropia. In one group, patients undergo medial rectus resection together with lateral rectus recession. In the other group, patients undergo medial rectus plication together with lateral rectus recession. Both procedures aim to improve ocular alignment, but they may differ in their effects on focusing ability, also called accommodation.
Before surgery, patients undergo a detailed ophthalmologic and strabismus examination, including measurement of ocular deviation and assessment of accommodative function. After surgery, patients are followed and reassessed to evaluate changes in eye alignment, surgical success, and accommodative parameters.
The purpose of this study is to evaluate and compare postoperative eye alignment, surgical success, and changes in accommodative function after these two surgical techniques. The study will help determine whether medial rectus plication and medial rectus resection have different effects on accommodation and surgical outcomes in patients treated for primary exotropia.
Detailed description
Primary exotropia is a common form of horizontal strabismus characterized by outward deviation of one eye. Surgical treatment is considered in patients with clinically significant deviation, stable ocular misalignment, symptoms, cosmetic concerns, or impaired binocular function. Horizontal strabismus surgery commonly includes weakening of the lateral rectus muscle, strengthening of the medial rectus muscle, or a combination of both procedures, depending on the measured deviation angle and clinical characteristics of the patient.
Medial rectus resection and medial rectus plication are two medial rectus strengthening techniques used in the surgical management of exotropia. Medial rectus resection involves disinsertion of the medial rectus muscle, removal of a measured segment of the muscle, and reattachment of the shortened muscle to the sclera. Medial rectus plication strengthens the medial rectus muscle by folding and suturing the muscle without complete disinsertion from its original scleral insertion. Because plication avoids full muscle disinsertion and may better preserve the anterior ciliary vessels and adjacent neurovascular structures, it has been proposed as a vessel-sparing and tissue-sparing alternative to resection.
The anterior ciliary arteries travel with the rectus muscles and contribute to the blood supply of the anterior segment, including structures related to accommodation such as the ciliary body and ciliary muscle. Accommodation is the focusing ability of the eye, especially important for near vision. Changes in extraocular muscle tension, ocular alignment, convergence, binocular interaction, and postoperative sensory adaptation may potentially influence accommodative parameters after strabismus surgery. Although the primary goal of exotropia surgery is improvement of ocular alignment, postoperative changes in accommodation may also affect visual comfort, near work, and binocular visual performance. Therefore, evaluation of accommodative changes may provide additional clinically meaningful information beyond motor alignment alone.
This prospective, interventional, comparative clinical study evaluates postoperative surgical outcomes and accommodative changes in patients with primary exotropia who underwent unilateral horizontal strabismus surgery.
Patients aged 5 to 40 years with basic primary exotropia were evaluated for eligibility. Eligible participants had literacy sufficient for accommodative testing, a stable deviation angle over three consecutive preoperative visits, and agreed to undergo unilateral surgery. Surgery was recommended for patients with a deviation angle of at least 20 prism diopters and a stable deviation angle over the last three visits. Patients were excluded if they had high refractive error, reduced best-corrected visual acuity, paralytic or restrictive strabismus, previous strabismus surgery, additional ocular disease, history of ocular trauma, long axial length, aphakia or pseudophakia, high accommodative convergence/accommodation ratio, systemic disease, or use of medications known to affect accommodation. Patients with incomplete examinations or loss to follow-up were excluded from the final analysis.
Participants were assigned to one of two parallel surgical groups according to an alternating sequential allocation method based on enrollment order. The first participant who consented to participate was assigned to the lateral rectus recession plus medial rectus resection group, and the second participant was assigned to the lateral rectus recession plus medial rectus plication group. Subsequent participants were assigned alternately thereafter. No randomization procedure was used.
Participants were assigned to one of two parallel surgical groups according to an alternating sequential allocation method based on enrollment order. The first participant who consented to participate was assigned to the lateral rectus recession plus medial rectus resection group, and the second participant was assigned to the lateral rectus recession plus medial rectus plication group. Subsequent participants were assigned alternately thereafter. No randomization procedure was used. The final analysis included 85 patients: 40 patients in the lateral rectus recession plus medial rectus resection group and 45 patients in the lateral rectus recession plus medial rectus plication group.
The primary functional assessment was accommodative amplitude. Accommodative amplitude was measured separately in each eye using the minus lens method by a single investigator. The highest minus lens power at which clear near vision was maintained was recorded, and 3.00 diopters were added to account for the 33-cm testing distance.
All surgeries were performed under general anesthesia by a single experienced strabismus surgeon. Participants underwent unilateral lateral rectus recession combined with either medial rectus resection or medial rectus plication according to group assignment.
Follow-up examinations were performed at postoperative week 1, postoperative month 1, and postoperative month 3. At each postoperative visit, best-corrected visual acuity, ocular motility, primary position deviation angle, and accommodative amplitude measurements were recorded. Postoperative accommodative changes were evaluated in both the operated and fellow eyes. Changes in accommodative amplitude from baseline to postoperative visits and between postoperative time points were compared within and between the surgical groups.
Surgical outcome was assessed using postoperative ocular alignment. Surgical success at postoperative month 3 was defined as a deviation in the primary position of 10 prism diopters or less of exotropia or 5 prism diopters or less of esotropia. Patients with residual exotropia of 12 prism diopters or more at postoperative month 3 were scheduled for additional surgery in the fellow eye after completion of the study follow-up period.
The main objective of the study is to compare postoperative accommodative changes after lateral rectus recession combined with medial rectus resection versus lateral rectus recession combined with medial rectus plication in patients with primary exotropia. Secondary objectives include comparison of postoperative ocular alignment, surgical success, and time-dependent changes in accommodative amplitude between the two surgical techniques.
By evaluating both motor alignment and accommodative outcomes, this study aims to clarify whether medial rectus plication and medial rectus resection provide comparable surgical correction and whether preservation of anterior segment vascular and neural structures during plication may be associated with different early postoperative accommodative changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with primary exotropia were assigned to one of two parallel surgical groups: medial rectus resection combined with lateral rectus recession or medial rectus plication combined with lateral rectus recession. Surgical outcomes and postoperative accommodative changes were compared between the groups. Participants were allocated sequentially to two parallel surgical groups in alternating order according to enrollment sequence. No randomization procedure was used.
| Arm | Type | Receives |
|---|---|---|
| Resection Group | Active comparator | Procedure: Lateral Rectus Recession combined with Medial Rectus ResectionParticipants in this arm underwent unilateral lateral rectus recession combined with medial rectus resection for the treatment of primary exotropia. Surgical dosage was planned according to the preoperative distance deviation angle. Postoperative follow-up examinations were performed at week 1, month 1, and month 3 to evaluate ocular alignment, surgical success, and accommodative amplitude. |
| Plication Group | Active comparator | Procedure: Lateral Rectus Recession combined with Medial Rectus PlicationParticipants in this arm underwent unilateral lateral rectus recession combined with medial rectus plication for the treatment of primary exotropia. Surgical dosage was planned according to the preoperative distance deviation angle. Postoperative follow-up examinations were performed at week 1, month 1, and month 3 to evaluate ocular alignment, surgical success, and accommodative amplitude. |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients aged 5 to 40 years.
- Diagnosis of basic primary exotropia.
- Stable deviation angle over three consecutive preoperative visits.
- Deviation angle of at least 20 prism diopters.
- Literacy and cooperation sufficient to perform accommodative amplitude testing.
Key exclusion criteria (14 listed)
- Spherical refractive error greater than ±5.00 diopters.
- Cylindrical refractive error greater than ±3.50 diopters.
- Best-corrected visual acuity worse than 0.1 logMAR.
- Paralytic or restrictive strabismus.
- Previous strabismus surgery.
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 |
|---|---|---|
| Lateral Rectus Recession combined with Medial Rectus ResectionUnilateral horizontal strabismus surgery consisting of lateral rectus recession combined with medial rectus resection was performed for the treatment of primary exotropia. The lateral rectus muscle was weakened by recession, and the medial rectus muscle was strengthened by resection. In the resection procedure, the medial rectus muscle was isolated, disinserted, shortened by removing a measured segment according to the planned surgical dosage, and reattached to the sclera. Surgical dosage was determined according to the preoperative distance deviation angle. The procedure was performed under general anesthesia by an experienced strabismus surgeon. | Procedure or surgery | Resection Group |
| Lateral Rectus Recession combined with Medial Rectus PlicationUnilateral horizontal strabismus surgery consisting of lateral rectus recession combined with medial rectus plication was performed for the treatment of primary exotropia. The lateral rectus muscle was weakened by recession, and the medial rectus muscle was strengthened by plication. In the plication procedure, the medial rectus muscle was folded and sutured to strengthen the muscle without complete disinsertion from its original scleral insertion. Surgical dosage was determined according to the preoperative distance deviation angle. The procedure was performed under general anesthesia by an experienced strabismus surgeon. | Procedure or surgery | Plication Group |
Primary outcome
Change in Accommodative Amplitude
Time frame: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3
Accommodative amplitude was measured separately in each eye using the minus lens method. Measurements were performed before surgery and during postoperative follow-up. The change in accommodative amplitude was calculated by comparing postoperative values with the baseline preoperative value. Measurements were recorded in diopters.
2 secondary outcomes
Ocular Alignment
Time frame: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3
Surgical Success
Time frame: Postoperative month 3
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 9 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no specific data-sharing plan was included in the study protocol or informed consent documents. Deidentified aggregate data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.
Related trials for Primary Exotropia
Active, not recruiting
Bilateral Lateral Rectus Recession Versus Bilateral Primary Medial Rectus Resection in Intermittent Exotropia
Intermittent Exotropia
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 Lateral Rectus Recession combined with Medial Rectus Resection and Lateral Rectus Recession combined with Medial Rectus Plication in people with Primary Exotropia and Strabismus, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 14 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 9 Jun 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 Turkey (Türkiye). 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?
Change in Accommodative Amplitude (time frame: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3). 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 9 Jun 2026.