Efficacy of a New Fixation Method (Intraocular Lens Suspension Method) for Intraocular Lenses (LS-313MF15)

JRCT ID: jRCT1022230027

Registered date:17/10/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Lens reconstruction patients
• Date of first enrollment: 17/10/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Fixation of an approved intraocular lens by applying existing surgical techniques commonly used in ophthalmology.

Outcome(s)

• Primary Outcome: Naked eye visual acuity (distance, intermediate, near), corrected visual acuity (distance, intermediate, near), intraocular pressure,Ref value, corneal endothelial cell count, flare cell meter, and anterior segment optical coherence tomography to check for complications such as IOL eccentricity and tilt, iris capture, etc.tilt, iris capture, and other complications.
• Secondary Outcome: Flare value

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

(1) Adult patients (18 years of age or older) undergoing lens reconstruction in cases of lens capsule breakage, rupture of the inferior canthus, or fragility of the inferior canthus that may lead to long-term intraocular lens fallout.
(2) Patients who are expected to visit the hospital regularly for at least six months for treatment.
(3) Patients who freely give their consent in writing.

Exclude criteria

(1) Cases of corneal opacity to the extent that the fixation status of the intraocular lens cannot be determined.
(2) Patients with retinal or uveal diseases
(3) Patients with a history of allergy to local anesthesia or sedative-analgesic drugs
(4) Patients with a preoperative corneal endothelial cell count of less than 1500 cells
(5) Patients for whom this procedure is found to be technically difficult before or during surgery
(6) Patients whose consent cannot be obtained
(7) Patients who are pregnant or have the possibility of pregnancy.

Related Information

• Primary Sponsor: Toru Nakazawa