ClinicalTrials.gg
CompletedNCT07637253Updated Jun 9, 2026

Accommodative Changes After Medial Rectus Resection Versus Plication in Primary Exotropia

An interventional study of Lateral Rectus Recession combined with Medial Rectus Resection and Lateral Rectus Recession combined with Medial Rectus Plication in Primary Exotropia, Strabismus and Strabismus Surgery, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Başakşehir Çam & Sakura City Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2024, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Non-randomized
Ages
5 Years to 40 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Primary Exotropia
  • Strabismus
  • Strabismus Surgery
  • Exotropia
  • Accomodation

Keywords

  • accomodative amplitude
  • primary exotropia
  • exotropia
  • strabismus surgery
  • plication
  • resection
03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's enrollment of 85 is above the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.

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

04

Who can participate

Ages eligible
5 Years to 40 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

  • 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 obtained from the participant and/or legal guardian.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Active comparator
    Resection Group

    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.

    Procedure: Lateral Rectus Recession combined with Medial Rectus Resection

  • Active comparator
    Plication Group

    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.

    Procedure: Lateral Rectus Recession combined with Medial Rectus Plication

Interventions

  • ProcedureLateral Rectus Recession combined with Medial Rectus Resection

    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.

  • ProcedureLateral Rectus Recession combined with Medial Rectus Plication

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3

Secondary outcomes

  1. 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.

    Time frame: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3

  2. 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.

    Time frame: Postoperative month 3

07

Study locations

1 site
  • University of Health Sciences, Basaksehir Cam and Sakura City Hospital
    Istanbul, Basaksehir 34490, Turkey (Türkiye)
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

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 Jan 2024 to primary completion in Jun 2025, 17 months.

Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 17 months is close to that.

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

Registered
Jun 4, 2026
First posted
Jun 9, 2026
StartActual
Jan 18, 2024
Primary completionActual
Jun 20, 2025
CompletionActual
Aug 15, 2025
Last update
Jun 9, 2026
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 Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07637253
Responsible party
Idıl Celen (Ophthalmologist, MD, FEBO, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
Jun 9, 2026
Start date
Jan 18, 2024
Primary completion
Jun 20, 2025
Completion
Aug 15, 2025
Last update
Jun 9, 2026

Oversight

Data monitoring committee
No
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 Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion