Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients (T-IOL)
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|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
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|
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 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|
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
- 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.
- 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).
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
|Contact: Antonio M Fea, MD, PhD||+39 011 566 email@example.com|
|Ophthalmology Institute, University of Turin||Recruiting|
|Turin, Italy, 10138|
|Contact: Antonio M Fea, MD, PhD +39 011 566 6039 firstname.lastname@example.org|
|Principal Investigator:||Antonio M Fea, MD, PhD||Department of Surgical Sciences, Ophthalmology Institute, University of Turin|