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临床试验/NCT05311917
NCT05311917招募中不适用

To Compare Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2022年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
treatment success criteria

研究概览

简要总结

convergence insufficiency is one of the most common binocular vision problems in which the eyes tend to have more exophoria in near than distance activities. Its prevalence is typically reported from 2.25% to 29.6% depending on the study population and its definition. Most of its symptoms include difficulty seeing at close works, headache, eye pain during study, blurred vision, diplopia, movement of words in reading, a feeling of pressure in the eye, and lack of concentration. Its signs include increasing near point of convergence, more exophoria at near than distance, decreased AC / A ratio, decreased positive fusional vergence.

In patients with convergent insufficiency, the first valid and standard questionnaire to assess the frequency and type of symptoms used before and after convergence insufficiency treatment is the convergence insufficiency symptom survey (CISS) questionnaire.

Generally, vision therapy is the first choice for convergence insufficiency management and the other choice is base in prism prescription. On the other hand, due to the changes in the interaction of the accommodation and convergence systems with increasing age, It is necessary to study how these systems interact and compare their responses to the active treatment of vision therapy and inactive prescription of base in prism.

In this controlled study, investigators will evaluate and compare the effect of vision therapy and base in prism prescription in patients over 40 years of age. this investigation will help to clarify which treatment is more effective.

This study will have two phases. In the first phase, investigators will seek to check the reliability and validity of the Persian version of CISS questionnaire for the elderly patients. For this purpose, investigators will use the Persian version questionnaire in previous study that assessed for young adults, and the investigators will modify it and check the reliability and validity of the final Persian version for subjects with presbyopia. This modified CISS questionnaire will be investigated in the elderly participants and the appropriate cut off point to differentiate between the normal group and the group with convergence insufficiency will be determined.

in the second phase one optometrist (Z.K.R) will do the preliminary examination and another optometrist (S.A) will do the interventions. After the initial examination and having the inclusion criteria, patients will be invited to participate in the study, the nature of the research will be explained to subjects and informed consent will be obtained from them. Before randomization, patients are asked to complete the CISS questionnaire and submit this questionnaire to Optometrist No. 1 (Z.K.R).According to the randomization all patients will be assigned to one of the treatment or control groups by optometrist No. 1. Vision therapy exercises, necessary trainings and prescriptions are given to all patients by Optometrist No. 2 (S.A).For the participants in the control group only near glasses will be prescribed as a conventional treatment, for the second group near glasses with base in prism according to sheard's criterion will be prescribed and in the third group, the prescription of near glasses will be given along with the complete training of the home exercises.

详细描述

Between non-strabismic binocular vision problems, convergence insufficiency is the most common problem (6) even in people with presbyopia this problem has high prevalence. (11) The most common ocular finding in these patients is an increase in near exophoria and thus reduces person's performance in activities such as reading, computer working and near activities. (12) Despite the effectiveness of vision therapy in reducing patients' symptoms and improving visual function, the different accommodation and vergence systems in the elderly may cause different results (1) so a comprehensive study of adult patients over the age of 40 with convergence insufficiency is needed. According to our knowledge the only study in these patients was done by MH Birnbaum (13) in 1999 which had several limitations. For example, in their study, the results were classified and recorded as success and failure in functional therapy and improvement or non-improvement of asthenopia; Success in treatment was achieved when two criteria were met: 1. The criterion of asthenopia includes achieving the ability to study for at least one hour without diplopia; And the ability to study without headache, eye pain and loss of concentration at least 75% of the time 2- Achieving 3 options of functional criteria including having an appropriate near point of convergence, having appropriate near point of convergence with red lens, having low near phoria and positive fusional vergence.

Another problem of this study was: not using the CISS questionnaire, which is a valid questionnaire of convergence insufficiency, and only considered success in treatment based on the two criteria, it should be mentioned that in their study the method for patients' selection did not report; On the other hand, the study was not blind, the importance of designing blind studies has been proven. Only one study by B Teitelbaum assessed prism prescription in patients over 40 years with convergence insufficiency (14) their study had two main problems, first: selected patients did not necessarily have convergence insufficiency, because the two basic criteria for convergence insufficiency (near point of convergence and positive fusion vergence) did not include in their study. Second: not using commercial progressive add lenses in patients glasses and it was unique lens with special design with limitation in base in prism prescription.

Because of the effects of various factors on vision therapy including patients' motivation, lack of cooperation in eye exercise, inappropriate age and unfavorable economic conditions, (especially in developing countries like Iran) or pandemic condition like COVID19 pandemy, vision therapy may not always be possible (1-3) and clinicians may have to prescribe base in prism for these patients. On the other hand, due to the changes in accommodation and convergence system and their interaction with aging (1, 3-4) study of their responses to the two types of treatments including active vision therapy and passive base in prism therapy and comparing them are noticeable matter and solving this challenge is absolutely necessary.

This study includes two phases. In the first phase, investigators will evaluate the reliability and validity of the Persian version of questionnaire for the elderly patients, this version was validated for young patients (38). Investigators will modify this questioner for presbyopic patients. For this purpose, six optometrists experienced in binocular vision will assess the questioner in two aspects: validity and reliability.

The validity of the modified Persian CISS include face validity (use of meaningful words), content validity (relevancy, clarity, comprehensiveness), discriminant validity Using a 6-point Likert scale (very weak, weak, moderate, good, very good, best), face validity will be assessed according to the aspects of fluency in elderly patients' cultural acceptance in iran and a score of ≥4 for each question will be passable. Content validity will be determined based on 1-relevancy (the extent to which the question of interest can being closely connected or appropriate for characteristics of the content under study), 2-clarity (appropriateness of the selected items in terms of being coherent and intelligible in concept and writing style), and 3-comprehensiveness (the ability of the questioner to cover all domains related to the topic under study). Relevancy and clarity will be assessed item by item and for the whole items in the questioners using a 4-point Likert scale (1-undesirable, 2-relatively desirable, 3-desirable, 4-completely desirable), and the Item Content Validity Index (I-CVI) and Scale Content Validity Index (S-CVI) will be calculated for the indices. Universal agreement approach will be used to check, the I-CVI value and it will be between 0-100%, and I-CVI≥ 0.8 will be considered passable. 20 The S-CVI for relevancy and clarity will be determined by averaging all I-CVI values. Comprehensiveness will be only measured at the scale level using a 4-point Likert scale (1- incomprehensive, 2- relatively comprehensive, 3- comprehensive, and 4- totally comprehensive). Then, the reliability of the questionnaire will be assessed using test-retest reliability analysis between first and second questioner administration in a group of 50 presbyopic patients aged 40-60 with convergence insufficiency. The elderly participants will be asked to participate in a second administration of the questionnaire 7-14 days later. To assess discriminant validity, convergence insufficiency will be categorized to 3 groups of mild (PFV ≥1.50 × near exophoria), severe (PFV < near exophoria), and moderate (values in between these groups) based on the severity of clinical manifestations according to the Convergence Insufficiency Treatment Trial guideline, and the mean overall CISS score Will be compared between these three groups.

研究设计

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • CISS score more than the estimated cut off point
  • Best corrected visual acuity=20/20 for near and far
  • Having Convergence Insufficiency
  • Near exophoria should be at least 4 prisms more than distant exophoria
  • NPC more than 6 cm
  • Inadequate near-positive positive fusion according to the Convergence Insufficiency Treatment Trial (CITT) study (8)
  • Normal monocular accomodation amplitude according to Hofster formula

排除标准

  • Any type of strabismus
  • Refractive error more than 6 diopters
  • Patients with history of prism prescription
  • History of vision therapy from 5 years ago
  • History of strabismus surgery or refractive error surgery
  • History of eye trauma
  • Use of any ophthalmic or general ophthalmic drugs affect ocular accommodation such as phenylephrine, anticholinergic drugs (mydriatics), carbonic anhydrase inhibitors, antihistamines, morphine and its derivatives, antidepressants amphetamine and imipramine
  • More than one prism of vertical phoria
  • Any mechanical limitations in the eye muscles
  • Ocular muscle paralysis
  • Any systemic and neurological diseases affecting binocular vision such as diabetes, myasthenia gravis, Graves', multiple sclerosis

结局指标

主要结局

treatment success criteria

时间窗: 2 month after intervention

achieving near point of convergence below 6 cm or 4 cm reduction in its distance, positive fusional vergence according to sheard criterion or grater than 15 prism or 10 prism improvement. achieving normal limit in CISS or 10 score improvement in total score.

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

Saeid Abdi

Principal Investigator

Shahid Beheshti University of Medical Sciences

研究点 (2)

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