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Accommodative Changes After Medial Rectus Resection Versus Plication in Primary Exotropia

4 giugno 2026 aggiornato da: Idıl Celen, Başakşehir Çam & Sakura City Hospital

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.

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

85

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Basaksehir
      • Istanbul, Basaksehir, Turchia (Türkiye), 34490
        • University of Health Sciences, Basaksehir Cam and Sakura City Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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 informed consent obtained from the participant and/or legal guardian.

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
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.
Comparatore attivo: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Accommodative Amplitude
Lasso di tempo: 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.
Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ocular Alignment
Lasso di tempo: Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3
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.
Baseline (preoperative), postoperative week 1, postoperative month 1, and postoperative month 3
Surgical Success
Lasso di tempo: Postoperative month 3
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.
Postoperative month 3

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 gennaio 2024

Completamento primario (Effettivo)

20 giugno 2025

Completamento dello studio (Effettivo)

15 agosto 2025

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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