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The Residential Ocular Care Study: A Multi-Centered, Randomized Controlled Clinical Trial comparing the effectiveness of an innovative and comprehensive new eye care model with usual care for individuals in Residential Aged Care Facilities

The Residential Ocular Care Study: A Multi-Centered, Randomized Controlled Clinical Trial comparing the effectiveness of an innovative and comprehensive new eye care model with usual care for individuals in Residential Aged Care Facilities

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000587505
Enrollment
395
Registered
2015-06-04
Start date
2014-06-18
Completion date
2018-06-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The ROC study aims to compare the effectiveness of a new model of eye care (Residential Ocular Care) with the Usual care received in aged care homes on presenting and best corrected near and distance vision. It will also assess the effectiveness off ROC on various aspects of quality of life, depression, rate of falls and eye care utilisation.

Interventions

The intervention is the Residential Ocular Care (ROC) intervention model, which is a novel model of eye care for people living in residential care facilities. This comprehensive model includes a thorough on-site eye examination with four subsequent intervention options for those with vision impairment, namely: (a) refraction and spectacle provision - glasses will be prescribed; (b) cataract surgery - participants will be referred to the Royal Victorian Eye and Ear hospital as a public patient

The intervention is the Residential Ocular Care (ROC) intervention model, which is a novel model of eye care for people living in residential care facilities. This comprehensive model includes a thorough on-site eye examination with four subsequent intervention options for those with vision impairment, namely: (a) refraction and spectacle provision - glasses will be prescribed; (b) cataract surgery - participants will be referred to the Royal Victorian Eye and Ear hospital as a public patient where surgery costs will be covered, or they can elect to go privately but will have to cover any out of pocket costs. Reimbursement will be covered for travel to and from the surgery as well as for preop assessments and 2 post op assessments; (c) low vision rehabilitation - participants will be referred to Vision Australia where low vision therapists will conduct a low vision examination and dispense low vision aids. A follow up session and training session on how to use the aids will also be provided; and (d) referral to an ophthalmologist for medical and surgical treatments for conditions likely to cause loss of sight or ocular discomfort. If our vision assessment uncovers cases of vision impairment not covered by the other interventions a referral will be made to an appropriate ophthalmologist at a local public hospital for medical treatment or surgical interventions as required at no cost to the participant. Participants will only be given one of the 4 interventions specified above that best suits their need. The ROC Model of care will be administered at Baseline visits where one of the four interventions will be given. Quality of life questionnaires will be administered at baseline, 2 month and 6 month. At 6 month optometrists will conduct another comprehensive eye tests The onsite comprehensive eye examinations are carried out by the Optometrist from the Australian College of Optometry and involve testing of visual acuity, subjective refraction and reading fluency. Examinations will be carried out to assess intraocular eye pressures, visual fields and dilated examinations of the back of the eye. Scans will also be taken of the back of the eye.

Sponsors

Centre for Eye Research Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria (i) Presenting distance vision of 6/15 or less and/or Near vision of N8 or less in both eyes (ii) Ability to speak English (iii) People deemed not cognitively impaired as determined by the Psychogeriatric Assessment Scale (PAS) questionnaire. A score of <15 in the PAS is deemed eligible. (iv) Ability to undergo visual acuity testing and provide reliable results

Exclusion criteria

Exclusion Criteria (i) Presenting distance vision of 6/12 or better and/or Near vision of better than N8 in both eyes (ii) Inability to speak English (iii)People with a cognitive impairment as determined by the Psychogeriatric Assessment Scale (PAS) questionnaire. A score of >15 in the PAS is deemed ineligible. (iii) Non-english speaking residents (iv) inability to be tested for vision (v) contraindication(s) as indicated by general practitioner responsible for residents care.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026