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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Visual Acuity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- Visual Satisfaction(when using a contact lens (0 day,7 days, 14 days))
- Change in Contrast sensitivity(when using a contact lens (0 day,7 days, 14 days))
- Visual Clarity(when using a contact lens (0 day,7 days, 14 days))
Investigators
Dwie Aprina
Principal investigator
Indonesia University