Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05208658
Other study ID # Vergence VT Protocol
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2, 2021
Est. completion date March 29, 2022

Study information

Verified date January 2022
Source Universitat Politècnica de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A vision therapy protocol for vergence ability is mentioned. The purpose of this study is to evaluate objectively the change in the vergence responses of binocular and accommodative normal subjects after performing a classic vision therapy protocol. This study is an interventional, cross-over, and randomized study.


Description:

After the first evaluation, subjects will be classified in the Experimental Group (EG) or Control Group (CG) randomly. There will be 18 subjects in each group. A classic vision therapy protocol for fusional vergence will be performed in the EG and the CG will be doing a placebo therapy, based on studies done before. The EG will do weekly office-based therapy of 45 minutes during 12 weeks and the CG will do weekly office-based placebo therapy of 15 minutes during 12 weeks. This placebo therapy will consist of smooth-pursuit and discrimination exercises that do not influence vergence response. The office-based done by the EG consists of a vergence therapy and its protocol will follow Scheiman's indications protocol. This vision therapy will train both positive and negative fusional vergence amplitudes in the same proportion. A pre-evaluation, a during evaluation, and a post-evaluation will be done at weeks 1, 6, and 12 respectively to all subjects. After the post-evaluation week, the CG will do 12 weeks more of office-based therapy but, this group will do the same conventional vergence protocol as EG. The CG will be evaluated at week 18, and finally, at week 24. During the evaluations, the vergence eye movements will be measured during the positive and negative fusional vergence tests. The break and the recovery points will be evaluated to all the subjects with three different methods performed in a randomized order: (1) objective computer-based test in the haploscopic system, (2) prism bar, and (3) phoropter rotary prisms. All these tests will be performed at 40 cm with a classic central visual target. This study aims to evaluate objectively the change in the vergence responses of binocular and accommodative normal subjects after performing a classic vision therapy protocol.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date March 29, 2022
Est. primary completion date March 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Normal binocular and accommodative subjects will participate in the study. All subjects have to fulfill the inclusion criteria. All evaluations will consist of the following objective and subjective optometric tests, which will be executed for all participants. 1. Monocular and binocular VA at near and distance with their habitual correction 2. Refractive error measured with the Grand Seiko WAM-5500 Autorefractor 3. Cover Test at near (40 cm) 4. Near Point of Accommodation 5. Near Point of Convergence 6. Vergence Facility Test at near (40 cm) 7. Monocular and binocular Accommodation Facility Test at near (40 cm) 8. Negative and Positive Relative Accommodation Test (ARN and ARP) 9. Random Dot 2 Stereo acuity Test 10. CISS questionnaire 11. Fusional Vergence Amplitude using both subjective and objective methods Exclusion Criteria: - having eye surgery - having an eye pathology - having a binocular or an accommodative disorder - using orto-K lenses

Study Design


Intervention

Other:
Experimental: Classical Vision Therapy Treatment
Do classical vision therapy treatment for improve vergence
Control: Eye Movement Therapy Treatment
Do eye movement therapy treatment in order not to improve vergence

Locations

Country Name City State
Spain Cristina Rovira-Gay Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Politècnica de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Alvarez TL, Scheiman M, Santos EM, Morales C, Yaramothu C, D'Antonio-Bertagnolli JV, Biswal BB, Gohel S, Li X. The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data. — View Citation

Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336. — View Citation

Scheiman M, Chase C, Borsting E, Mitchell GL, Kulp MT, Cotter SA; CITT-RS Study Group. Effect of treatment of symptomatic convergence insufficiency on reading in children: a pilot study. Clin Exp Optom. 2018 Jul;101(4):585-593. doi: 10.1111/cxo.12682. Epu — View Citation

Scheiman M, Mitchell GL, Cotter S, Cooper J, Kulp M, Rouse M, Borsting E, London R, Wensveen J; Convergence Insufficiency Treatment Trial Study Group. A randomized clinical trial of treatments for convergence insufficiency in children. Arch Ophthalmol. 20 — View Citation

Scheiman M, Mitchell GL, Cotter S, Kulp MT, Cooper J, Rouse M, Borsting E, London R, Wensveen J. A randomized clinical trial of vision therapy/orthoptics versus pencil pushups for the treatment of convergence insufficiency in young adults. Optom Vis Sci. — View Citation

Scheiman M, Talasan H, Alvarez TL. Objective Assessment of Disparity Vergence after Treatment of Symptomatic Convergence Insufficiency in Children. Optom Vis Sci. 2019 Jan;96(1):3-16. doi: 10.1097/OPX.0000000000001320. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective vergence response: To evaluate objectively the change in positive and negative fusional vergence at near of binocularly and accommodative normal subjects after performing a vision therapy It is measured objectively with an haparoscopic setup and eye movements were recorded with an Eyelink 1000 Plus (SR Research) at 500Hz. Firstly, stimulus disparity changed smoothly at 1PD/s up to 45PD for both divergence (BI) and convergence (BO), mimicking a Risley prism. Secondly, the disparity was changed in steps of 2PD mimicking a prism bar. Break and recovery points were determined offline using a custom Matlab code for the analysis of eye movements.
Measurements will be compared before and after the therapy treatment.
Through study completion, an average of 6 months
Primary Subjective vergence response: To evaluate objectively the change in positive and negative fusional vergence at near of binocularly and accommodative normal subjects after performing a vision therapy It is evaluated with the clinical methods measured subjectively using the Risley prism of the phoropter and the Prism Bar.
Measurements will be compared before and after the therapy treatment.
Through study completion, an average of 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05600140 - Viewing Strategy Training in Children With (Cerebral) Visual Impairment N/A
Active, not recruiting NCT03872479 - Single Ascending Dose Study in Participants With LCA10 Phase 1/Phase 2
Active, not recruiting NCT02595502 - Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses N/A
Completed NCT02485054 - A Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances (VASCO)
Completed NCT00985231 - Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers N/A
Recruiting NCT06077682 - Cycloplegic Refraction in Pediatric Patients With Esotropia Phase 4
Active, not recruiting NCT04123626 - A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene Phase 1/Phase 2
Recruiting NCT04693247 - Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction N/A
Completed NCT01318577 - Study of A New Contact Lens Cleaning and Disinfecting Solution N/A
Completed NCT03763721 - The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation N/A
Completed NCT05602402 - To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use N/A
Not yet recruiting NCT06085430 - Kubota Glass Parameter Refinement Study N/A
Completed NCT04347564 - Usability of the Software MacuFix for the Categorization of Metamorphopsia
Completed NCT01546402 - Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema Phase 4
Completed NCT01698788 - Effect of Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in Diabetic Macular Edema N/A
Completed NCT03169855 - Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability
Terminated NCT03913130 - Extension Study to Study PQ-110-001 (NCT03140969) Phase 1/Phase 2
Recruiting NCT03479021 - SPOT Vision Screening
Completed NCT03780257 - Study to Evaluate Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene Phase 1/Phase 2
Recruiting NCT04855045 - An Open-label, Dose Escalation and Double-masked, Randomized, Controlled Trial Evaluating Safety and Tolerability of Sepofarsen in Children (<8 Years of Age) With LCA10 Caused by Mutations in the CEP290 Gene. Phase 2/Phase 3