In a new study published in Optometry & Vision Science, investigators evaluated the safety of contact lens use in pediatric patients.
Their purpose: To provide recommendations and identify gaps in current literature for future studies.
Give me some background first.
Despite the increasing use of contact lenses for correcting pediatric refractive error, there is limited information available regarding the safety of contact lenses for pediatrics.
“With limited information on the safety profiles of contact lenses in children, it is important to characterize the current understanding and promote this device's safe and effective use”, the authors commented.
Now, talk about the study.
Researchers conducted a literature search of studies that reported on the safety and or complications associated with contact lens use for correcting refractive errors in pediatrics aged 0 to 10.
The literature search involved the following databases:
- MEDLINE via PubMed
- EMBASE
- The Cochrane Library
- Trial registries
- U.S. FDA clinical trial documentation
Who was included in the study?
The investigation examined 73 studies from 10 countries that utilized differing contact lens methods—most commonly orthokeratology (ortho-k) and soft contact lenses— for children aged 6 to 18.
What kinds of studies were analyzed?
The studies included in the analysis were comprised of:
- Experimental and quasi-experimental studies
- Observational studies
- Prospective and retrospective cohort
- Case-control
- Analytical cross-sectional studies
- Case series of 30 or more participants
How was the study conducted?
Two independent reviewers screened articles for eligibility, and then extracted the following data:
- Participant details
- Context
- Study methods
- Key findings relevant to the review question
Note: A third reviewer resolved disputes regarding a study’s eligibility.
Findings?
It was found that corneal staining was the most common adverse event and was reported in:
- 60% of studies using ortho-k
- 45% of studies using soft contact lens
The most common adverse events (AEs) in randomized controlled trials (RCTs) were:
- Corneal staining/Punctate keratitis
- Typically considered mild
Go on …
Other AEs reported in the studies were:
- Infiltrative keratitis and corneal abrasion
- 16% of studies
- Allergic reaction/conjunctivitis
- 12% of studies
- Lens binding (adherence)
- 10% of studies
- Contact lens–related peripheral ulcer/sterile ulcer
- 8% of studies
- Microbial keratitis
- 6% of studies
- Contact lens papillary conjunctivitis
- 4% of studies
- Unspecified keratitis
- 4% of studies
What were the severities of adverse events?
- Serious or significant AEs were reported in 30% of studies
- Nonserious/mild or moderate AEs were reported in 4% of studies
- “Any” AEs were reported in 14% of studies
Note: Discontinuation of the study due to AEs was noted in 24% of studies
Limitations?
Currently, there are no uniform reporting standards for AEs, which created challenges for data synthesis.
Additionally, there was little information concerning contact lens care guidance, hygiene, and how variations of these aspects in clinical practice could have impacted the safety profile data.
Expert opinion?
The authors recommended that future studies should focus on standardized reporting protocols for pediatric contact lens studies to allow for more vigorous comparisons across investigations.
Take home.
Among the data analyzed, corneal staining was the most common AE.