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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric Nanoflex IOL | Experimental | Phacoemulsification with toric Nanoflex IOL implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phacoemulsification with toric Nanoflex IOL implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rotational stability of the toric intraocular lens (T-IOL). | 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. | Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Correction of the astigmatism. | Effective correction evaluated through corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA). | Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio M Fea, MD, PhD | Contact | +39 011 566 6039 | antoniomfea@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio M Fea, MD, PhD | Department of Surgical Sciences, Ophthalmology Institute, University of Turin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Institute, University of Turin | Recruiting | Turin | 10138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19101427 | Background | Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg. 2009 Jan;35(1):70-5. doi: 10.1016/j.jcrs.2008.09.027. | |
| 10590003 | Background | Rashad KM. Laser in situ keratomileusis for myopic astigmatism. J Refract Surg. 1999 Nov-Dec;15(6):653-60. doi: 10.3928/1081-597X-19991101-09. |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| NanoFlex toric Intraocular Lens | Device |
|
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| D059708 | Ultrasonic Surgical Procedures |