Convergence Insufficiency Clinical Trial
Official title:
To Compare Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency
NCT number | NCT05311917 |
Other study ID # | 1400.610 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2022 |
Est. completion date | August 2023 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | August 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: Any type of strabismus Amblyopia 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 Nystagmus Any systemic and neurological diseases affecting binocular vision such as diabetes, myasthenia gravis, Graves', multiple sclerosis |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Shahid Beheshti University of Medical Sciences | Tehran |
Lead Sponsor | Collaborator |
---|---|
Shahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | treatment success criteria | 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. |
2 month after intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03248336 -
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
|
N/A | |
Recruiting |
NCT05262361 -
Persistent Post-Concussion Symptoms With Convergence Insufficiency
|
N/A | |
Terminated |
NCT03123822 -
Spectacles Lens in Concussed Kids
|
N/A | |
Completed |
NCT00472407 -
Screening for Convergence Insufficiency in School-age Children
|
||
Completed |
NCT00347945 -
Randomized Trial of Treatments for Convergence Insufficiency
|
Phase 3 | |
Completed |
NCT05070767 -
Neurolens Headache Study
|
N/A | |
Completed |
NCT03319966 -
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
|
||
Recruiting |
NCT04691427 -
Effectiveness of Virtual Reality Vision Therapy - VERVE
|
Early Phase 1 | |
Terminated |
NCT05087563 -
Neurolens Convergence Insufficiency Study
|
N/A | |
Completed |
NCT02607384 -
The Baltimore Reading and Eye Disease Study
|
N/A | |
Active, not recruiting |
NCT02207517 -
Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency
|
Phase 3 | |
Completed |
NCT00347581 -
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
|
Phase 3 | |
Recruiting |
NCT05603962 -
The Effectiveness of Visual Training in Convergence Insufficiency Patients
|
N/A | |
Completed |
NCT01515943 -
Convergence Insufficiency Treatment Study (CITS)
|
N/A | |
Recruiting |
NCT05877560 -
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
|
N/A | |
Recruiting |
NCT05948046 -
The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
|
||
Active, not recruiting |
NCT00338611 -
Convergence Insufficiency Treatment Trial (CITT)
|
Phase 3 | |
Recruiting |
NCT05012384 -
Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.
|
N/A | |
Recruiting |
NCT05761106 -
Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders
|
N/A | |
Completed |
NCT02510040 -
A Prospective Observational Study of Adult Strabismus
|