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

Visual Acuity Reduced Transiently Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724525
• Other study ID #: 20-070-0813
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: December 19, 2020

Study information

• Verified date: January 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 19, 2020
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Visual Acuity Reduced Transiently

Intervention

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

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Contrast sensitivity	Value obtained on examination of the Pelli Robson Chart in Poly Neurooftlamology. Examination conducted by researchers (DA).	when using a contact lens (0 day,7 days, 14 days)
Secondary	Visual Clarity	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	when using a contact lens (0 day,7 days, 14 days)
Secondary	Visual Satisfaction	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)	when using a contact lens (0 day,7 days, 14 days)