Evidence map›Paper›PMID 37843772›Full record

ArticleOphthalmology and therapy2023

Allogeneic Serum Eye Drops: A Randomized Clinical Trial to Evaluate the Clinical Effectiveness of Two Drop Sizes.

Christie Vermeulen, Lars L J van der Burg, Nan van Geloven, Catharina A Eggink, Yanny Y Y Cheng, Rudy M M A Nuijts, Robert P L Wisse, Chantal M van Luijk, Carla Nieuwendaal, Lies Remeijer and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03539159 (Allogenic Serum Micro Eye Drops Compared to Conventional Sized Eye Drops), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03539159 naunknown statusnot on this map

Allogenic Serum Micro Eye Drops Compared to Conventional Sized Eye Drops: A Prospective Randomized Non-inferiority, Investigator Masked, Cross-over Multicenter Clinical Study

TypeinterventionalSponsorSanquin Research & Blood Bank DivisionsRan2018 to 2020Enrolled54ConditionsDry Eye SyndromeArmsAllogeneic conventional sized serum eye drops, Allogeneic micro sized serum eye drops
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Optimizing instilled drug delivery: a scoping review of microdrops in ophthalmology.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  5. Nanomedicine in Ophthalmology: From Bench to Bedside.Journal of clinical medicine · 2024
    Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Christie VermeulenDepartment of Product and Process Development, Sanquin Blood Bank, Plesmanlaan 125, 1066 CX, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0003-4575-2874
Lars L J van der BurgDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
Nan van GelovenDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
Catharina A EgginkDepartment of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.
Yanny Y Y ChengDepartment of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.
Rudy M M A NuijtsUniversity Clinic for Ophthalmology, Maastricht, The Netherlands.
Robert P L WisseDepartment of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.
Chantal M van LuijkDepartment of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.
Carla NieuwendaalDepartment of Ophthalmology, University Medical Center Amsterdam, Location AMC, Amsterdam, The Netherlands.
Lies RemeijerThe Rotterdam Eye Hospital, Rotterdam, The Netherlands.
Pieter F van der MeerDepartment of Product and Process Development, Sanquin Blood Bank, Plesmanlaan 125, 1066 CX, Amsterdam, The Netherlands.
Dirk de KorteDepartment of Product and Process Development, Sanquin Blood Bank, Plesmanlaan 125, 1066 CX, Amsterdam, The Netherlands.
Thomas R L KleiDepartment of Product and Process Development, Sanquin Blood Bank, Plesmanlaan 125, 1066 CX, Amsterdam, The Netherlands. t.klei@sanquin.nl.
Sanquin · NLLeiden University Medical Center · NLUniversity Medical Center Utrecht · NLAmsterdam University Medical Centers · NLMaastricht University · NLRadboud University Nijmegen · NLRotterdam Eye Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAllogeneic serum from blood donors is starting to be used to treat patients with dry eye disease (DED). However, the optimal dose is not known. We therefore aimed to evaluate the clinical efficaciousness and user-friendliness of micro-sized versus conventional-sized allogeneic serum eye drops (SEDs).

methodsIn a randomized trial, patients with DED first receive micro-sized SEDs (7 µl/unit) for 1 month, followed by a 1-month washout, before receiving conventional-sized SEDs (50 µl/unit) for 1 month; or vice versa. The primary endpoint was the Ocular Surface Disease Index (OSDI) score. Secondary endpoints were tear break-up time (TBT), tear production (TP), and presence of corneal punctate lesions (CP). The user-friendliness of both application systems was also compared. A linear mixed model for cross-over design was applied to compare both treatments.

resultsForty-nine patients completed the trial. The mean OSDI score significantly improved from 52 ± 3 to 41 ± 3 for micro-sized SEDs, and from 54 ± 3 to 45 ± 3 for conventional-sized SEDs. Non-inferiority (margin = 6) of micro-sized SEDs was established. We demonstrate a significant improvement for TBT in case of conventional-sized SEDs and for CP in both treatment groups. TP trended towards an improvement in both treatment groups. The user-friendliness of the conventional drop system was significantly higher.

conclusionsFor the first time, non-inferiority of micro-sized allogeneic SEDs was established. The beneficial effect of both SED volumes was similar as measured by the OSDI score. Although user-friendliness of the micro drop system was significantly lower, it is an attractive alternative as it saves valuable donor serum.

trial registrationClinicalTrials.gov (NCT03539159).

Indexed as

Allogeneic serum eye dropsApplication systemDrop sizeDry eye disease (DED)Naïve patients with DEDOcular Surface Disease Index (OSDI)Randomized clinical trial

Identifiers

PMID37843772
PMCPMC10640534
OpenAlexW4387660780

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.