Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser

Обзор

The goal of this clinical trial is to collect information on vision outcomes in people aged 45 to 65 who have difficulty seeing clearly at near distances due to aging (a condition called presbyopia). All participants will receive the same treatment: laser eye surgery with the PRESBYOND method using the MEL 90 excimer laser. The main questions this study aims to answer are: * How well do patients see at distance, intermediate, and near after treatment? * How satisfied are patients with their vision after surgery? Participants will: * Attend seven visits over six months (before surgery and after surgery at 1 day, 1 week, 1 month, 3 months, and 6 months) * Undergo laser eye surgery with PRESBYOND * Complete vision tests and questionnaires about their experience There is no comparison group in this study.

Вмешательства

• Устройство MEL90 excimer laser - PRESBYOND
  Participants will undergo laser eye surgery in both eyes using the PRESBYOND method. First, a thin flap is created on the surface of the eye using a femtosecond laser. Then, a second laser (excimer laser) reshapes the cornea to improve vision at near, intermediate, and far distances. The treatment is similar to monovision techniques, where one eye is mainly corrected for distance and the other for near vision. However, PRESBYOND differs by adjusting the depth of focus in each eye individually,

Первичные конечные точки

• Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better [Срок оценки: 6 months after surgery]

Критерии участия

Критерии включения

• Subjects between 45 and 65 years old
• Scheduled to undergo bilateral LASIK treatment with PRESBYOND
• Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
• Normal corneal topography in each eye
• Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination
• Residual stromal thickness ≥250 microns in each eye
• Availability, willingness, to comply with examination follow up visits
• Signed informed consent and data protection documents
• Patients successfully passed the tolerance test

Критерии исключения

• Mixed astigmatism in any eye
• Irregular corneal astigmatism in any eye
• Clinically significant ocular surface disease in any eye
• History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye
• Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
• Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye
• Clinically significant pupil abnormalities in any eye
• Use of systemic or ocular medications that may affect visual outcomes
• Systemic pathology that may affect the results of the study
• Pregnancy or being treated for conditions associated with hormonal fluctuation
• Participation in another clinical trial in the last 30 days

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австралия · 2 центра

• Eye Laser Specialists — Melbourne
• Crystal Eye and laser Center — Craigie

Новая Зеландия · 1 центр

• The Wellington Eye Centre — Wellington

Идентификаторы

NCT: NCT06960785 · GPAS-REF-024-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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