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

NCT ID: NCT04724525

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2020-12-19

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.

Conditions

Visual Acuity Reduced Transiently

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Interventions

soft contact lens Toric

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dwie Aprina

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

20-070-0813

Identifier Type: -

Identifier Source: org_study_id