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

NCT04724525 | Completed DMC

• 1 other identifier: 20-070-0813
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Toric soft contact lens

Outcome Measures

Primary Outcomes (1)

• Change in Visual Acuity

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

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

Secondary Outcomes (3)

• 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)

• Visual Satisfaction

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

Interventions

soft contact lens Toric OTHER

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

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: November 17, 2020
• Primary Completion: December 19, 2020
• Study Completion: December 19, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

ID (1)