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Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial - CORE-RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52771
Enrollment
70
Registered
2021-03-01
Start date
2021-04-22
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

cataract. lens opacification

Interventions

Subjects in the telemonitoring group will have a post-operative follow-up by teleconsultations with online questionnaires and a web-based eye exam.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Planned for bilateral phacoemulsification cataract extraction and intra-ocular lens implantation (either sequential or in one procedure) - >= 18 years of age - No other current ophthalmic conditions or history that negatively influence post-operative visual acuity - Be able to fill out the health questionnaires (in Dutch, German or English) and perform the web-based refractive assessment (possibly with assistance of family member or other close relative). - Specific digital requirements include access to a computer and a smartphone and knowledge how to log in to an online patient portal.

Exclusion criteria

Exclusion criteria: - Cataract extraction surgery combined with other procedures, including: keratoplasty, vitrectomy, glaucoma filter implants - Ocular comorbidities that negatively influence post-operative visual acuity - No access to the digital requirements to take the online health questionnaire and/or perform the online refraction. - Insufficient command of the Dutch, German or English language to understand the questionnaires and instructions of the web-based refractive assessment or no family member / close relative to assist with this - Inability of performing the web-based eye exam prior to cataract surgery.

Design outcomes

Primary

MeasureTime frame
costeffectiveness

Secondary

MeasureTime frame
Corrected distance visual acuity at the final post-operative visit, uncorrected distance visual acuity, refractive error (sphere/cylinder/axes), patient reported outcome measurements, adverse events.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)