Clincosm LogoSign in Get a demo

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

Sponsor
University of Turin, Italy (Other)
Overall Status
Unknown status
CT.gov ID
NCT02412215
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
30.1
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Phacoemulsification with toric Nanoflex IOL implantation
  • Device: NanoFlex toric Intraocular Lens
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients Undergoing Cataract Surgery
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Toric Nanoflex IOL

Phacoemulsification with toric Nanoflex IOL implantation

Procedure: Phacoemulsification with toric Nanoflex IOL implantation
A self-sealing incision is made with a 2.2mm knife at 110°. Phacoemulsification is performed. The foldable nanoFlex toric IOL is injected in the capsular bag using the nanoPoint single-use injector system (STAAR) or 1620 sofTip Injector (ASICO). The IOL is rotated to align the cylinder axis with the steep corneal meridian using Z align function by Callisto Eye. Every movement of the IOL axis marks are noted.

Device: NanoFlex toric Intraocular Lens

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmology Institute, University of Turin Turin Italy 10138

Sponsors and Collaborators

  • University of Turin, Italy

Investigators

  • Principal Investigator: Antonio M Fea, MD, PhD, Department of Surgical Sciences, Ophthalmology Institute, University of Turin

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Antonio Fea, Antonio Fea MD. PhD, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT02412215
Other Study ID Numbers:
  • 0026769
First Posted:
Apr 9, 2015
Last Update Posted:
Apr 9, 2015
Last Verified:
Apr 1, 2015
Additional relevant MeSH terms:
Astigmatism

Study Results

No Results Posted as of Apr 9, 2015