跳至主要内容
临床试验/NCT06937489
NCT06937489已完成不适用

The Effect of the Changes in Cylinder Power and Axis of Toric Soft Contact Lenses on the Visual Quality, Satisfaction and Vision Acceptability in Astigmatic Subjects

Indonesia University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Monocular clarity

研究概览

简要总结

Toric SCL combined spheric lens power with cylinder power and axis. However, in Indonesia, the availability of cylinder power and axis parameter variations between products are still narrow, with stock-keeping units (SKUs) options only between 0.75-2.75 DC and 10o-180o for power and axis, respectively. Providing accurate toric SCL prescription for astigmatism patient in Indonesia remains a challenge for ophthalmologists and generally could not be achieved. Therefore, the aim of this study is to investigate the effect of power undercorrection and axis misalignment on visual acuity, contrast sensitivity, visual clarity, visual satisfaction, and vision acceptability.

The inclusion criteria for the trial, include: (1) 20 to 40 years of age without the need for presbyopic correction, (2) mild to moderate myopia patients, sphere between -1.00 and - 6.00 D combined with cylinder between -0.75 to -3.00 DC in at least one eye, (3) corrected distance visual acuity (VA) of with Toric SCL 6/15 or better bilaterally. Exclusion criteria include: (1) a history of contact lens use 6 months prior to trial, (2) history of previous ocular surgery, (3) anterior and posterior segment abnormalities, (4) manifest strabismus or dry eye, and (5) ocular and systemic diseases that would preclude CL wear or decrease visual acuity; and pregnancy or lactation.

详细描述

Detailed Procedure

Baseline refraction and clinical manifestations were determined during initial visit which each participants attended three assessment visits on a separate day. Baseline visual acuity was measured using Snellen chart, contrast sensitivity was measured using Pelli-Robson chart, and VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure monocular clarity (1=blurred, 10=clear), satisfaction (1=satisfied, 10=unsatisfied), and vision acceptability (1=unacceptable, 10=perfectly acceptable).

Participants were fitted on their diseased eye, which could be unilateral or bilateral, with the toric SCL. Lens fit (corneal coverage, centration, movement, and rotation) was examined using slit-lamp examination. Regarding lens rotation, modification of the toric SCL axis was determined using the "LARS" (left add, right subtract) method for proper contact lens fitting. The shifting axis in toric SCL was assessed by observing the shift marker on contact lens in a clockwise or anticlockwise direction; then if any, it was corrected using LARS formula. A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

The assessment visits interval is 1 week and completed exactly on day 14 after their first baseline visit. At each assessment visit, three different cylinder power were tested: 1) full cylinder power, 2) under-correction of cylinder power by 0.5 D, and 3) under-correction of cylinder power by 1.0 DC. Axis was also misaligned by -10° and +10° for each cylinder power alteration. The powers and axis assigned to the participants were randomized during every assessment visit. Baseline assessments and treatment allocations were masked to both patients and physician. All assessments were carried out on the day of observation and recorded on the subject evaluation sheet in accordance with the sample data, in which examinations results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The participants, the ophthalmologist conducting the eye examinations, and the outcome assessors will be blinded to group allocation.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •20 to 40 years of age without the need for presbyopic correction
  • •mild to moderate myopia patients, sphere between -1.00 and - 6.00 D combined with cylinder between -0.75 to -3.00 DC in at least one eye
  • •corrected distance visual acuity (VA) of with Toric SCL 6/15 or better bilaterally.

排除标准

  • •a history of contact lens use 6 months prior to trial
  • •history of previous ocular surgery
  • •anterior and posterior segment abnormalities
  • •manifest strabismus or dry eye
  • •ocular and systemic diseases that would preclude CL wear or decrease visual acuity; and pregnancy or lactation.

研究组 & 干预措施

Undercorrection of toric soft contact lens

Experimental

A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

干预措施: Hydrogel conventional toric lenses with undercorrection of 0.5 D (Device)

Undercorrection of toric soft contact lens

Experimental

A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

干预措施: Hydrogel conventional toric lenses with undercorrection of 1.0 D (Device)

Axis misalignment of toric soft contact lens

Active Comparator

A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

干预措施: Hydrogel conventional toric lenses with -10° axis misalignment (Device)

Axis misalignment of toric soft contact lens

Active Comparator

A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

干预措施: Hydrogel conventional toric lenses with +10° axis misalignment (Device)

结局指标

主要结局

Monocular clarity

时间窗: Week 1 and week 2

VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure monocular clarity (1=blurred, 10=clear)

Visual satisfaction

时间窗: Week 1 and week 2

VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure visual satisfaction (1=satisfied, 10=unsatisfied)

Vision acceptability

时间窗: Week 1 and week 2

VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure vision acceptability (1=unacceptable, 10=perfectly acceptable).

Visual acuity

时间窗: Week 1 and week 2

Visual acuity was measured using Snellen chart and reported with logMAR

Contrast sensitivity was measured using Pelli-Robson chart,

时间窗: Week 1 and week 2

Contrast sensitivity was measured using Pelli-Robson chart,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Tri Rahayu, SpM(K), FIACLE

Ophthalmologist at the Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Indonesia University

研究点 (1)

Loading locations...

相似试验