Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients (T-IOL)

University of Turin

Status: Unknown

Conditions: Astigmatism

Treatments: Procedure: Phacoemulsification with toric Nanoflex IOL implantation; Device: NanoFlex toric Intraocular Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT02412215

0026769

Details and patient eligibility

About

This study aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.

The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.

Full description

A good rotational stability of toric intraocular lenses (T-IOL) allows an accurate refractive correction. However, many aspects -both pre-operative and post-operative- can interfere causing T-IOL rotation and misalignment.

Complete preoperative ocular evaluation is performed including slit-lamp examination, uncorrected distance visual acuity (UDVA), best-corrected visual acuity (BCVA), Javal keratometry, corneal Scheimplug tomography (Pentacam), optical biometry (IOL Master), Goldman applanation tonometry and fundus evaluation through dilated pupils. The spherical IOL power is calculated considering the axial length obtained with optical biometry, the magnitude of astigmatism derived from Javal keratometry and the steepest axis obtained with corneal tomography. The power of the toric IOL is determined with the online Staar Toric IOL calculator. The reference landmarks are also marked preoperatively with a sterile methylene blue fine point pen. The marking is rechecked in the operating theatre with the electronic toric marker ASICO.

Postoperative evaluation for IOL alignment and rotational stability is performed with slit-lamp photography on dilated pupils. Images are captured with Haag Streit slit lamp BQ 900 and are evaluated with the image-analysis software Protractor (Staar).

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of 60 years of age ore more
• Cataract
• Corneal astigmatism of 1 diopter (D) or more

Exclusion criteria

• Primary or secondary pathological conditions of the cornea
• Zonular fibres pathologies (phacodonesis, pseudoexfoliation syndrome)
• Irregular astigmatism (corneal scar, keratoconus, pterygium)
• Traumatic cataract
• Previous ocular surgery
• Complications during cataract surgery

Trial design

60 participants in 1 patient group

Toric Nanoflex IOL

Experimental group

Description:

Phacoemulsification with toric Nanoflex IOL implantation

Treatment:

Procedure: Phacoemulsification with toric Nanoflex IOL implantation

Device: NanoFlex toric Intraocular Lens