Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients

Not Applicable

• Conditions: Astigmatism
• Interventions: Procedure: Phacoemulsification with toric Nanoflex IOL implantation; Device: NanoFlex toric Intraocular Lens

• Registration Number: NCT02412215
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-29
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-08
• Last Update Submitted: 2015-04-08
• Study First Posted: 2015-04-09
• Last Update Posted: 2015-04-09
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toric Nanoflex IOL	Phacoemulsification with toric Nanoflex IOL implantation	Phacoemulsification with toric Nanoflex IOL implantation
Toric Nanoflex IOL	NanoFlex toric Intraocular Lens	Phacoemulsification with toric Nanoflex IOL implantation

Primary Outcome Measures

Name	Time	Method
Change in rotational stability of the toric intraocular lens (T-IOL).	Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.	The misalignment of the lens is defined as the difference (Δ) between the intended axis and the actual axis of the new collameric Nanoflex T-IOL by STAAR.

Secondary Outcome Measures

Name	Time	Method
Correction of the astigmatism.	Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery	Effective correction evaluated through corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA).

Trial Locations

Locations (1)

Ophthalmology Institute, University of Turin; 🇮🇹 Turin, Italy