Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

NCT00825747 | Withdrawn DMC

• 1 other identifier: SeeLensAF 65
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cataract

Keywords

Cataract; Cataract surgery; intraocular lens; Aspheric lens

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity 3 months after SeeLens AF implantation

  3 months

Secondary Outcomes (3)

• Complications related to SeeLens AF implantation during cataract surgery.

  3 months

• Postoperative severe intra-ocular inflammation or infection

  3 months

• Prediction of ocular refraction after cataract surgery with Seelens AF implantation

  3 months

Interventions

SeeLens AF intra-ocular lens DEVICE

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.

Also known as: aspheric SeeLens

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Senile Cataract
• Age \>18 years
• Cataract extraction using phacoemulsification
• Corneal incision less than 1.5 mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (2)

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Meir Medical Center

Kfar Saba, 44410, Israel

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yokrat Ton, MD

  Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2009
• First Posted: January 21, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

IL (2)