Clinical trial NCT04724525: Changes in Power and Cylinder Axis of Toric Soft Contact Lenses (LKL)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity Reduced Transiently
Keywords: Toric soft contact lens
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 20 - 35 years
2. 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
3. Minimum astigmatism component ≥0.75 D and maximum ≤ 3 D in one eye
4. The best visual acuity after corrected by LKL Torik is better or equal to 6/15

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Visual Acuity
timeFrame: when using a contact lens (0 day,7 days, 14 days)
Secondary outcomes:
measure: Change in Contrast sensitivity
timeFrame: when using a contact lens (0 day,7 days, 14 days)
measure: Visual Clarity
timeFrame: when using a contact lens (0 day,7 days, 14 days)
measure: Visual Satisfaction
timeFrame: when using a contact lens (0 day,7 days, 14 days)
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Jakarta
Study officials:
References: