Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

Not Applicable

Suspended

• Conditions: h25; Senile cataract

• Registration Number: DRKS00005696
• Lead Sponsor: PowerVision, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1.Patients must be eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction.

2.Patients should have a best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester)

3.Patients predicted best corrected distance visual acuity must be 20/40 or better after cataract removal and AIOL implantation as determined by potential acuity meter (PAM) or other potential vision tests or surgeon estimation on both eyes.
4.Patients must have =1.0 D of preoperative keratometric astigmatism.
5.Patients must have clear intraocular media other than cataract.
6.Patients must have a preoperative endothelial cell density of 2200 cells/mm2 or more.
7.Patients must be at least 50 years of age.
8.Patients must be willing and able to comply with schedule for follow-up visits for thirty six months after surgery.
9.Patients must have a calculated AIOL power within the range of the investigational device;
10.Patients must provide written informed consent.

Exclusion Criteria

1.Patients must not be taking medications that may affect accommodation (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents).
2.Patients must not have systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes).
3.Patients must not have systemic medications that may confound the outcome or increase the risk to the subject i.e tamsulosin hydrochloride (Flomax) or other medications with similar side effects.
4.Patients must not have ocular conditions that may predispose for future complications (e.g. anterior segment pathology including glaucoma or potentially occludable angles, corneal dystrophy, ocular inflammation, poor pupil dilation).
5.Patients must not have previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
6.Patients must not be pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes.
7.Patients must not have degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
8.Patients must not have conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome).
9.Patients must not have sensitivity to planned study medications.
10.Patients must not be simultaneously participating in other ophthalmic drug or device clinical trial.
11.Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract extraction and lens implantation.
12.Patients who have floppy/weak zonules, incomplete zonules or zonular rupture during cataract extraction.
13.Patients who have a capsulorhexis size of <5.5 mm or >6.0 mm.
14.Patients who have a decentered capsulorhexis of >1.0 mm in relation to the limbus.
15.Patients with posterior capsular opacity observed after cataract extraction.
16.Patients with complicated cataract surgery or damage to AIOL that prevents implantation of the AIOL (e.g. pupillary constriction, poor visibility due to corneal edema).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective accommodative amplitude after 6 months using an auto refractometer.<br><br>Best corrected distance visual acuity of logMAR of 0.3 or better.<br><br>Rates of serious adverse events at 6 months.