Prevalence of Binocular Vision Anomalies Before and After Cataract and Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Changes from pre-surgical accommodative facility at 12 weeks post surgery (refractive error group only)
研究概览
简要总结
There are indications in the literature that binocular vision disorders may occur after cataract and corneal refractive surgery. It is not clear whether these problems are new or represent decompensation of previously existing conditions. However, the following significant study limitations exist in the current literature: 1) lack of attention to non-strabismic binocular vision disorders, 2) incomplete binocular vision assessment, 3) a validated symptom survey was not used, 4) diplopia was typically the only symptom studied, 5) retrospective study design, and 6) in the few prospective studies the sample sizes were small.
Given the limitations in the current literature there is a need for further study of the prevalence and significance of binocular vision problems after cataract surgery and binocular vision and accommodative problems after corneal refractive surgery.
This study aims to determine whether there is an increase in the prevalence of binocular vision problems after cataract surgery and accommodative and binocular vision disorders after refractive surgery.
详细描述
- Research plan Specific aim 1A: To investigate the prevalence of non-strabismic and strabismic binocular vision anomalies after cataract surgery. Specific aim 1B: To investigate the prevalence accommodative and binocular vision disorders after refractive surgery. Specific aim 2: To determine if increase in the prevalence of binocular anomalies is different for cataract surgery compared to refractive surgery. Specific aim 3: To develop an efficient examination protocol that would enable eye care professionals to determine if a patient is at risk for binocular vision anomalies after cataract surgery and accommodative and binocular vision disorders after refractive surgery.
The proposed study will address the weaknesses in the current literature. The study will be prospective and will use explicit and well-defined eligibility and exclusion criteria. A comprehensive battery of accommodative (pre-presbyopes only) and binocular vision tests will be administered on all the patients before the surgery of the first eye and 12 weeks after the surgery of the second eye.
A pre-defined classification protocol will be used to determine if a binocular vision disorder is present before surgery, after surgery, or whether there has been a change in the condition after surgery.
A total prevalence of postoperative strabismic and non-strabismic binocular vision anomalies will be determined for the cataract population and the refractive error group. 2. Statistical analysis plan 2.1 Specific aim 1A Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision anomalies after cataract surgery
A sample size calculation based on a McNemar's test to compare the prevalence of binocular vision anomalies before and after cataract surgery was performed using the Power and Sample Size Program (PS version 3.1.2). Base on a previous literature, the overall prevalence of accommodative and binocular vision anomalies in adult population (18-35 years) is 13.15%. However, no existing literature reported the prevalence of binocular vision anomalies after cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract patients who are willing to undergo cataract extraction and intraocular lens implantation
- •Refractive error patients who are willing to undergo laser corneal refractive surgery
- •18 years and older in cataract group
- •18-35 years old in refractive error group
- •Any gender
- •Any race or ethnicity
- •Informed consent and willingness to participate in the study
排除标准
- •Other ocular pathology that affect vision and binocular alignment in addition to cataract or refractive error
- •Surgical complications that may affect binocular vision testing, such as a subluxation of the IOLs or macular edema
结局指标
主要结局
Changes from pre-surgical accommodative facility at 12 weeks post surgery (refractive error group only)
时间窗: Pre-surgery and 12 weeks post surgery
Accommodative facility will be measured using monocular accommodative facility testing (in cycle per minute).
Changes from pre-surgical phoria at 12 weeks post surgery
时间窗: Pre-surgery and 12 weeks post surgery
Phoria will be measured using cover test (in prism diopters).
Changes from pre-surgical fusional vergence at 12 weeks post surgery
时间窗: Pre-surgery and 12 weeks post surgery
Fusional vergence will be measured using step vergence testing (in prism diopters).
Changes from pre-surgical vergence facility at 12 weeks post surgery
时间窗: Pre-surgery and 12 weeks post surgery
Vergence facility will be measured using vergence facility testing (in cycle per minute).
Changes from pre-surgical accommodative amplitude at 12 weeks post surgery (refractive error group only)
时间窗: Pre-surgery and 12 weeks post surgery
Accommodative amplitude will be measured using monocular amplitude of accommodation testing (in diopters).
Changes from pre-surgical convergence amplitude at 12 weeks post surgery
时间窗: Pre-surgery and 12 weeks post surgery
Convergence amplitude will be measured using near point of convergence test (in centimeters).
次要结局
- changes from pre-surgical CISS score at 12 weeks post surgery(pre-surgery and 12 weeks post surgery)
- changes from pre-surgical stereopsis at 12 weeks post surgery(pre-surgery and 12 weeks post surgery)
- changes from pre-surgical aniseikonia at 12 weeks post surgery(pre-surgery and 12 weeks post surgery)