Assessment of Functional Vision in Parkinsons Disease

Completed

Conditions: Parkinsons disease,

Registration Number: CTRI/2023/08/056262

Lead Sponsor: Sushma

Brief Summary: This study will begin after obtaining IRC and IEC approvals and Registration in Clinical Trial Registry- India. Informed consent will be obtained from the participants before proceeding with the study. Participants will be recruited based on inclusion and exclusion criteria. Individuals between 30-70 years of age with Parkinsonâ€™s disease will be recruited for the study. After taking a detailed history of participants and assessing baseline examination including hand-held slit lamp and fundus evaluation for inclusion criteria, functional vision will be assessed with non-contact methods including a visual acuity test using log MAR chart (distance, near), Pelli-Robson contrast sensitivity, color vision, stereopsis, Amsler grid, and confrontation test for the visual field, ocular motility, pupillary examination. Best corrected visual acuity for distance will be assessed using Log MAR visual acuity chart and N-notation for near visual acuity, where participants are asked to identify the letters at a specific testing distance. The pupillary examination will be performed using a pen torch with dim room illumination. An ocular motility test will be performed by showing the target to the participant at one arm’s distance and asking them to follow the target without rotating their head to assess the movements and alignment of eyes. The stereopsis test will be assessed using the Random stereo test and participants are asked to identify the shapes during testing. Then, Colour vision perception will be assessed using HRR (Hardy-Rand-Rittler) pseudo isochromatic color vision plates where a participant’s one eye will be occluded to assess monocularly. Contrast sensitivity will be measured using a Pelli-Robson contrast sensitivity chart at 100cm (both monocular and binocular) and the Visual field will be tested monocularly using an Amsler grid at the participant’s comfortable reading distance to assess the central field of vision and for overall field of vision, confrontation test will be assessed one eye at a time at one arm distance. The entire process might take half an hour. This study does not involve any invasive procedure and any second visit assessments. No additional costs for participating in the study. All tests done are part of the standard of care. After collecting the required data, the results will be noted and analyzed to quantify the changes in functional vision parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 26

Inclusion Criteria

Individuals diagnosed with Parkinsonâ€™s disease will be included.

Exclusion Criteria

Individuals with a history of traumatic brain injury, Individuals with ocular/ systemic disease on any medications which are known to affect the visual function, Individuals with one eye, Those with amblyopia or tropia, Diagnosed with dementia (as documented in the report).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity (log unit), Ocular motility	Baseline data and functional vision assessment (on the same day)
(Normal/abnormal), Pupillary reaction (RAPD +ve/-ve), Depth perception (seconds of arc), Color	Baseline data and functional vision assessment (on the same day)
perception (Normal/abnormal), Contrast sensitivity (log unit), Visual field (Normal/abnormal)	Baseline data and functional vision assessment (on the same day)

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (1): Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Sushma
Principal investigator
8105660202
sushma.mchpmpl2022@learner.manipal.edu