Clinical Trials

Inclusion Criteria:

• Is aphakic or functionally aphakic due to dislocated crystalline lens, crystalline lens material, or IOL at screening (Note: All eyes will undergo lens/IOL removal, if applicable, and vitrectomy on Operative day prior to implantation of the LensOne).

• Has inadequate capsular support (i.e. not suitable for sulcus IOL implantation or otherwise rescuable with a Capsular Tension Ring (CTR)) and would otherwise be a candidate for a scleral-fixated (posterior chamber IOL) PC-IOL

• Is a poor candidate for an ACIOL, due to at least one of the following factors:

  • Abnormal Angle

  • Shallow anterior chamber

  • Abnormal iris o Corneal endothelial disease

  • Glaucoma

  • Uveitis

• Horizontal White-to-white (WTW) of 11.0-13.0 mm by caliper measurement during the slit lamp exam

• Age: 22-85 years

• Must demonstrate visual potential with 6 lines or more of visual acuity (VA) improvement with best correction as compared to uncorrected visual acuity (UCDVA) in study eye at screening, and best corrected visual acuity (BCDVA) better than 20/70 in the fellow eye

• Able to comprehend and provide informed consent.

• Able and willing to attend all scheduled follow-up visits.

• Calculated IOL power with LensOne is within the range of the compatible IOL.

• Contact lens wearers must demonstrate stability (≤0.5D change between visits) of keratometry recorded at least one week apart after lens discontinuation

• Demonstration of keratometry stability by optical biometry (≤0.5 D between measurements). Note: if >0.5 D difference, 2 more measurements must be taken and all 4 measurements provided to the medical monitor.

Exclusion Criteria:

• Corneal opacification precluding visualization of intraocular structures

• Active retinal detachment or history of retinal detachment surgery within 12 months prior to Screening Visit

• Active retinal vascular diseases

• Active uveitis (infectious or non-infectious; anterior or posterior)

• Uncontrolled glaucoma

• History of endophthalmitis

• History of glaucoma filtering surgery, scleral buckle or strabismus surgery

• Need for concomitant glaucoma filtering surgery

• Ciliary body cyst larger than 0.5 mm

• Micro/nanophthalmos

• Known allergy to silicone implant material

• Active alcohol or narcotic dependence

• Psychiatric illness preventing reliable follow up

• Presence of or need for a silicone oil tamponade

• Pregnancy or lactation (Note: Female subjects of childbearing potential must have a negative urine pregnancy test at screening and Operative day)

• Concurrent participation in another drug or device investigation or who have participated in a drug or device trial within 30 days of the pre-operative visit

• Marfan syndrome or any disease involving scleral integrity.

• Contraindications to vitrectomy procedure including suspected or active ocular tumor

• Current or history of systemic condition (e.g., uncontrolled diabetes) that, based on the Investigator’s judgment, poses a concern for the subjects’ safety or could confound the outcomes of the study

Exclusion Criteria in the study eye at the time of surgery (prior to injection of LensOne):

• Retinal detachment

• Choroidal detachment (Hemorrhagic or serous)

• Retinal or Vitreous Hemorrhage (Note: dot blot heme is permitted)

• Evidence of retinal neovascularization

• Retinal ischemia

• Conjunctival scarring that precludes conjunctival coverage of footplates.

• Severe intraoperative iris trauma

• Need for any intraocular tamponade (air, gas, oil)

• Presence of any intraoperative finding or complication that in the judgement of the surgeon, requires the patient to be left aphakic or would confound the assessment of LensOne safety and effectiveness

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 05/18/2026. Questions regarding updates should be directed to the study team contact.