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NCT06937489

The Effect of the Changes in Cylinder Power and Axis of Toric Soft Contact Lenses on the Visual Quality, Satisfaction and Vision Acceptability in Astigmatic Subjects

Completed NA Last updated 22 April 2025
What this trial tests

NA trial testing Hydrogel conventional toric lenses with -10° axis misalignment in Astigmatism in 20 participants. Completed in 19 December 2020.

Timeline
16 November 2020
Primary endpoint
12 December 2020
19 December 2020

Quick facts

Lead sponsorIndonesia University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposedevice feasibility
Enrollment20
Start date16 November 2020
Primary completion12 December 2020
Estimated completion19 December 2020
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Indonesia University

Who can join

Adults 20 to 40, any sex, with Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Toric SCL combined spheric lens power with cylinder power and axis. However, in Indonesia, the availability of cylinder power and axis parameter variations between products are still narrow, with stock-keeping units (SKUs) options only between 0.75-2.75 DC and 10o-180o for power and axis, respectively. Providing accurate toric SCL prescription for astigmatism patient in Indonesia remains a challenge for ophthalmologists and generally could not be achieved. Therefore, the aim of this study is to investigate the effect of power undercorrection and axis misalignment on visual acuity, contrast sensitivity, visual clarity, visual satisfaction, and vision acceptability. The inclusion criteria for the trial, include: (1) 20 to 40 years of age without the need for presbyopic correction, (2) mild to moderate myopia patients, sphere between -1.00 and - 6.00 D combined with cylinder between -0.75 to -3.00 DC in at least one eye, (3) corrected distance visual acuity (VA) of with Toric SCL 6/15 or better bilaterally. Exclusion criteria include: (1) a history of contact lens use 6 months prior to trial, (2) history of previous ocular surgery, (3) anterior and posterior segment abnormalities, (4) manifest strabismus or dry eye, and (5) ocular and systemic diseases that would preclude CL wear or decrease visual acuity; and pregnancy or lactation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Astigmatism

Currently open trials in the same condition.

Other Indonesia University trials

Trials by the same sponsor.

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Data sources for this page

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