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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03454334
Other study ID # ShahedBU
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 11, 2013
Est. completion date January 14, 2020

Study information

Verified date June 2020
Source Shahid Beheshti University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.


Recruitment information / eligibility

Status Terminated
Enrollment 141
Est. completion date January 14, 2020
Est. primary completion date November 18, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Preoperative BCVA (distance) more impacted than 20/40 - Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision. - By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery. - Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities Exclusion Criteria: - Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism. - Large pupil - Corneal transplant surgery or previous glaucoma-filtering, - A history of retinal detachments. - Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis, - Endothelial disease - Iris neovascularization, and amblyopia)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
multifocal intraocular lens IOLs
clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shahid Beheshti University

Outcome

Type Measure Description Time frame Safety issue
Primary Contrast sensitivity mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved. 4 years
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