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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
NA trial testing Hydrogel conventional toric lenses with -10° axis misalignment in Astigmatism in 20 participants. Completed in 19 December 2020.
12 December 2020
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | device feasibility |
| Enrollment | 20 |
| Start date | 16 November 2020 |
| Primary completion | 12 December 2020 |
| Estimated completion | 19 December 2020 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Hydrogel conventional toric lenses with -10° axis misalignment
- Hydrogel conventional toric lenses with +10° axis misalignment
- Hydrogel conventional toric lenses with undercorrection of 0.5 D
- Hydrogel conventional toric lenses with undercorrection of 1.0 D
Conditions studied
- Astigmatism — all drugs for Astigmatism →
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.
Verify or expand the search:
- PubMed search for NCT06937489
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06937489 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indonesia University
- Last refreshed: 22 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06937489.
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