ArticleInternational journal of ophthalmology2017
Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays.
Article in International journal of ophthalmology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Small-aperture intracorneal inlay implantation in emmetropic presbyopic patients: a systematic review.Eye (London, England) · 2022Pooled it
- Refractive corneal inlay implantation outcomes: a preliminary systematic review.International ophthalmology · 2022Pooled it
- Topical lipoic acid choline ester eye drop for improvement of near visual acuity in subjects with presbyopia: a safety and preliminary efficacy trial.Eye (London, England) · 2021Trial
- Presbyopia: Current Perspectives and Prospects for Patients.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026Review
- Progressive Insights into 3D Bioprinting for Corneal Tissue Restoration.Advanced healthcare materials · 2026Review
- Current Trends in Presbyopia Correction-A Comprehensive Review.Journal of clinical medicine · 2025Review
- Treatments for Presbyopia.Deutsches Arzteblatt international · 2025Review
- Review of Presbyopia Treatment with Corneal Inlays and New Developments.Clinical ophthalmology (Auckland, N.Z.) · 2022Review
- Potential productivity loss from uncorrected and under-corrected presbyopia in low- and middle-income countries: A life table modeling study.Frontiers in public health · 2022Article
- Clinical performance of presbyopia correction with a multifocal corneoscleral lens.International journal of ophthalmology · 2021Article
- Histopathologic Analysis of Explanted KAMRA Corneal Inlays Demonstrating Adherent Fibroconnective Tissue Scar Formation.Ocular oncology and pathology · 2019Article
- Visual Prognosis after Explantation of Small-Aperture Corneal Inlays in Presbyopic Eyes: A Case Series.Medical hypothesis, discovery & innovation ophthalmology journal · 2019Article
- Visual Prognosis after Explantation of a Corneal Shape-Changing Hydrogel Inlay in Presbyopic Eyes.Medical hypothesis, discovery & innovation ophthalmology journal · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo provide a side-by-side analysis of the summary of safety and effectiveness data (SSED) submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia.
methodsSSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA), adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE), and achieved monocular uncorrected near visual acuity (UNVA) at 24mo.
resultsTotally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40) or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20) or better at 24mo.
conclusionBoth devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.