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Completed

NCT Number: NCT04724525

Changes in Power and Cylinder Axis of Toric Soft Contact Lenses (LKL)

Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. Due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to SKU limitations. This research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. The study was conducted at Kirana Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort using the VAS method.

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Key information

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 20 - 35 years
  • Patients who do not have a spherical size (plano) to mild-moderate myopia (-1.00 D to -6.00 D) with age over 18 years
  • Minimum astigmatism component ≥0.75 D and maximum ≤ 3 D in one eye
  • The best visual acuity after corrected by LKL Torik is better or equal to 6/15

Exclusion criteria

  • History of previous intraocular surgery.
  • History of contact lens use in the last 6 months.
  • history of dry eyes, uveitis, glaucoma and corneal and conjunctival disorders
  • posterior segment abnormalities that reduce the quality of vision
  • Patients with contraindications to wearing contact lenses
  • There are no toric LKLs with exactly the strength and axes required by the patient

Treatment and study plan

soft contact lens Toric

Other

soft contact lens toric with different axis and power that use in human's eye

Primary outcomes

  1. Change in Visual Acuity

    Time frame: when using a contact lens (0 day,7 days, 14 days)

    Visual acuity was measured using a Snellen chart at a distance of 6 meters by the researcher (DA) at Refractive Poly

Secondary outcomes

  1. Change in Contrast sensitivity

    Time frame: when using a contact lens (0 day,7 days, 14 days)

    Value obtained on examination of the Pelli Robson Chart in Poly Neurooftlamology. Examination conducted by researchers (DA).

  2. Visual Clarity

    Time frame: when using a contact lens (0 day,7 days, 14 days)

    Values were obtained by the VAS method. Research subjects were asked to name a number from 1-10 (score 1 indicates poor clarity, 10 indicates good clarity) to assess visual clarity

  3. Visual Satisfaction

    Time frame: when using a contact lens (0 day,7 days, 14 days)

    Values were obtained by the VAS method. The research subjects were asked to name a number from 1-10 (a score of 1 indicates dissatisfaction, 10 indicates very satisfied)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effect of Changes in Power and Cylinder Axis on Vision Quality, Satisfaction and Vision Acceptability of People With Mild-Medium Astigmatism With Toric Soft Contact Lenses (LKL)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2021
Registry last updated
Feb 1, 2021

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.

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