Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02412215
Recruitment Status : Unknown
Verified April 2015 by Antonio Fea, University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Antonio Fea, 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.


Condition or disease Intervention/treatment Phase
Astigmatism Procedure: Phacoemulsification with toric Nanoflex IOL implantation Device: NanoFlex toric Intraocular Lens Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

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



Primary Outcome Measures :
  1. Change in rotational stability of the toric intraocular lens (T-IOL). [ Time Frame: 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. [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412215


Contacts
Layout table for location contacts
Contact: Antonio M Fea, MD, PhD +39 011 566 6039 antoniomfea@gmail.com

Locations
Layout table for location information
Italy
Ophthalmology Institute, University of Turin Recruiting
Turin, Italy, 10138
Contact: Antonio M Fea, MD, PhD    +39 011 566 6039    antoniomfea@gmail.com   
Sponsors and Collaborators
University of Turin, Italy
Investigators
Layout table for investigator information
Principal Investigator: Antonio M Fea, MD, PhD Department of Surgical Sciences, Ophthalmology Institute, University of Turin

Publications:

Layout table for additonal information
Responsible Party: Antonio Fea, Antonio Fea MD. PhD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02412215     History of Changes
Other Study ID Numbers: 0026769
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Astigmatism
Refractive Errors
Eye Diseases