Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK

Corneal Astigmatism in Cataract Patients and Previous DALK Clinical Trial

Official title:

Customized Toric Intraocular Lens Implantation in Eyes With Cataract and Corneal Astigmatism After Deep Anterior Lamellar Keratoplasty (DALK): a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398109
• Other study ID #: N. 24/15/FB
• Status: Completed
• Phase: N/A
• First received: January 7, 2018
• Last updated: January 7, 2018
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2018
• Source: Fondazione G.B. Bietti, IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the purpose of this study was to assess the efficacy of custom made toric intraocular lens implantation in patients with simultaneous post-DALK high corneal astigmatism and cataract.

Description:

Patients undergoing cataract surgery after DALK for keratoconus were enrolled. Total corneal astigmatism (TCA)was assessed by a rotating Scheimpflug camera combined with Placido disk corneal topography (Sirius; CSO, Firenze, Italy). A customized toric IOL (FIL 611 T, Soleko) was implanted in all eyes. One year postoperatively, refraction was measured, the IOL position was recorded, and vectorial and non-vectorial analysis were performed to evaluate the correction of astigmatism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Corneal suture removal had been performed in all cases at least 1 year before cataract surgery.

Corneal astigmatism was stable at least since 6 months before the cataract surgery

Exclusion Criteria:

• other ocular pathologies as glaucoma, retinal disease.

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism in Cataract Patients and Previous DALK

Intervention

Device:
• Customized toric IOL for post-DALK atigmatism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione G.B. Bietti, IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure postoperative refractive astigmatism	Postoperative refractive astigmatism expressed in diopters and measured with refraction examination	6 months