Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

Cataract Clinical Trial

Official title:

Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00825747
• Other study ID #: SeeLensAF 65
• Status: Withdrawn
• Phase: N/A
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2021
• Source: Hanita Lenses
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.

Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.

Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.

Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Senile Cataract

• Age >18 years

• Cataract extraction using phacoemulsification

• Corneal incision less than 1.5 mm

Exclusion Criteria:

• Allergy/sensitivity to eye drops used during and after cataract surgery

• Amblyopia/ strabismus

• Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.

• previous ocular surgery or ocular trauma in the investigated eye

• Ocular anomaly, such as microphthalmos

• Keratometry values less than 40 diopters or more than 47 diopters.

• Ocular axial length less than 21.0 mm or longer than 25.0 mm

• Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.

• posterior capsular scar

• visual acuity in the fellow eye less than 20/200

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• SeeLens AF intra-ocular lens
the SeeLens AF is an acrylic hydrophilic C shaped haptics intra-ocular lens, designed for implantation in the lenticular capsular bag or the sulcus during cataract surgery.

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Hanita Lenses

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity 3 months after SeeLens AF implantation		3 months
Secondary	Complications related to SeeLens AF implantation during cataract surgery.		3 months
Secondary	Postoperative severe intra-ocular inflammation or infection		3 months
Secondary	Prediction of ocular refraction after cataract surgery with Seelens AF implantation		3 months