Accommodative Changes After Medial Rectus Resection Versus Plication in Primary Exotropia (NCT07637253) | Clinical Trial Compass
CompletedNot Applicable
Accommodative Changes After Medial Rectus Resection Versus Plication in Primary Exotropia
Turkey (Türkiye)85 participantsStarted 2024-01-18
Plain-language 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.
Who can participate
Age range
5 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.