Wide field digital eye imaging system for universal neonatal eye screening
Che Sarida CI, Khairil II, Roza S, Izzuna MM
Record ID 32018014781
English
Authors' objectives:
To evaluate the effectiveness, safety, and economic implications of
WFDI system for universal neonatal eye screening
Authors' results and conclusions:
Effectiveness:
WFDI system demonstrated superior diagnostic performance compared to RRT, detecting anterior and posterior segment abnormalities often missed by RRT. Detection rates ranged from4.7%to 41.2% (detect ocular abnormalities at early stage), with percentage requiring further interventions ranging from 11.1%to 59.4%(of all abnormalities).
Safety:
WFDIS is a safe and non-invasive tool with no significant adverse events reported. It is approved as a Class II medical device by the USFDA.
Organizational Challenges:
Implementing WFDIS requires significant investments in training,
infrastructure, and referral networks. WHO’s postnatal guidelines emphasize early screenings, but logistical barriers, particularly in resource-limited settings, remain.
Cost Effectiveness:
Though initial costs are higher than RRT (WFDIS: RM49.48/screening vs. RRT: RM 2.62), WFDIS offers long-term benefits, including reduced severe visual impairments. Total costs from 2026–2030 are estimated at RM 97.7M for WFDIS compared to RM 5.2M for RRT. Sensitivity analyses reveal substantial variations based on implementation scenarios.
Conclusion
A substantial fair level of retrievable evidence demonstrated that WFDI
as compared to RRT and IBO is a safe and well-tolerated screening modality in UNES and effective in providing good detection rate of
ocular abnormalities that usually missed by RRT. Organisational issues such as trained personel, referral mechanism, economic evaluation,
feasibility and cost in implementing UNES using WFDI need to be considered judiciously.
Authors' methods:
A systematic review was conducted. Review protocol and search strategy was developed by the main author while literature search was conducted by an Information Specialist who searched for published articles related to wide field digital retinal imaging (WFDI) in universal
neonatal eye screening. The following electronic databases were searched through the Ovid interface: MEDLINE (R) ALL 1946 toMay13th 2024. Parallel searches were run in PubMed, Embase USFDA and INAHTA database while additional articles were retrieved from reviewing the bibliographies of retrieved articles. The search was limited to articles on human. There was no language limitation in the search. The last search was conducted on May 13th 2024.
Details
Project Status:
Completed
Year Published:
2024
URL for published report:
https://www.moh.gov.my/index.php/database_stores/store_view_page/30/419
Requestor:
Opthalmologist
English language abstract:
An English language summary is available
Publication Type:
Mini HTA
Country:
Malaysia
MeSH Terms
- Neonatal Screening
- Eye Diseases
- Infant, Newborn
- Ophthalmoscopy
- Optical Imaging
- Image Processing, Computer-Assisted
Keywords
- Optical Imaging
- Computer assisted image processing
- Infant
- Newborn
Contact
Organisation Name:
Malaysian Health Technology Assessment
Contact Address:
Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229
Contact Name:
htamalaysia@moh.gov.my
Contact Email:
htamalaysia@moh.gov.my
Copyright:
Malaysian Health Technology Assessment Section (MaHTAS)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.