Clinical Study to Evaluate the Safety and Performance of the Intraocular Lens (Investigational Device Development Code: SP2Y-GMF) After Implantation.

JRCT ID: jRCT2072210002

Registered date:02/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 06/04/2021
• Target sample size: 64
• Study type: Interventional

Intervention(s)

Cataract sugery with posterior chamber lens preloaded in an injector.
Insert the injector nozzle through the incision and release the intraocular lens into the lens capsule. At that time, do not rotate the inserter itself. Pull the injector back from the incision and use a hook or other device to adjust the intraocular lens to the proper position.

Outcome(s)

Primary Outcome

Performance
1) Percentage of eyes with Uncorrected Near Visual Acuity 0.5 or more decimal at Month 4-6
2) Percentage of eyes with subjective astigmatism 0.50D or less at Month 4-6 in all eyes implanted with minimum cylinder power lens

Key inclusion & exclusion criteria

• Age minimum: >= 22age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with bilateral cataract, aged 22 or more years at the time of consent
2) Patients who desire to receive bilateral cataract surgery and implantation
3) Patients with planned 2nd eye surgery within the period of 7-30 days after the 1st eye surgery
4) Other patients who meet the inclusion crirteria stipulated in the clinical trial protocol

Exclude criteria

1) Patients with history of corneal transplant
2) Patients with history of refractive surgery
3) Patients with history of intraocular surgery
4) Patients with glaucoma
5) Patients with previous or acute retinal detachment
6) Patients with retinal degenerative disorders
7) Patients with a plan to have an intraocular surgery other than implantation of the investigational devices during the study period
8) Other patients who meet the exclusion crirteria stipulated in the clinical trial protocol

Related Information

• Primary Sponsor: Eguchi Shuichiro