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

SP2Y-GMF CLINICAL STUDY

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2072210002
Enrollment
64
Registered
2021-04-02
Start date
2021-04-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

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 rotat

Sponsors

Eguchi Shuichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

Contacts

Public ContactSoichiro Motono

HOYA CORPORATION Medical Division

mejp-chiken@hoya.com+81-3-5913-2347

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026