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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04724525
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 19

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity Reduced Transiently	Other: soft contact lens Toric	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• 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)
• Actual Study Start Date: Nov 17, 2020
• Actual Primary Completion Date: Dec 19, 2020
• Actual Study Completion Date: Dec 19, 2020

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitas Indonesia	Jakarta Pusat	Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dwie Aprina, Principal investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT04724525
• Other Study ID Numbers: 20-070-0813
• First Posted: Jan 26, 2021
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dwie Aprina, Principal investigator, Indonesia University: Toric soft contact lens

Study Results

No Results Posted as of Feb 1, 2021