Completed
NCT Number: NCT03398109
Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK
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.
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Age range
65 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Measure postoperative refractive astigmatism
Time frame: 6 months
Postoperative refractive astigmatism expressed in diopters and measured with refraction examination
Sponsors and collaborators
Lead sponsor
Fondazione G.B. Bietti, IRCCS
Other
Registry information
Official study title
Customized Toric Intraocular Lens Implantation in Eyes With Cataract and Corneal Astigmatism After Deep Anterior Lamellar Keratoplasty (DALK): a Prospective Study
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jan 12, 2018
- Registry last updated
- Jan 12, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.