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

Not Applicable

Completed

• Conditions: Visual Acuity Reduced Transiently

• Registration Number: NCT04724525
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-17
• Primary Completion: 2020-12-19
• Study Completion: 2020-12-19
• Status Verified: 2021-01
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Visual Acuity	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 Outcome Measures

Name	Time	Method
Visual Clarity	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
Visual Satisfaction	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)
Change in Contrast sensitivity	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).

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia