Evidence map›Paper›PMID 32672570›Full record

Trial reportOphthalmology. Glaucoma

Outcomes of the Shunt Tube Exposure Prevention Study: A Randomized Clinical Trial.

Hosam Sheha, Celso Tello, Lama A Al-Aswad, Mohamed S Sayed, Richard K Lee

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology. Glaucoma. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 24% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. [Research progress and applications of biologically derived materials in scleral reconstruction].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2026
    Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Review
  9. Reconstruction with umbilical amnion following ocular evisceration: A case study.American journal of ophthalmology case reports · 2022
    Article
  10. Combined umbilical cord patching with amniotic membrane graft for corneal surface reconstruction.Medical hypothesis, discovery & innovation ophthalmology journal · 2022
    Article
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

5 authors at 4 institutions in 1 country.

Hosam ShehaDepartment of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York; Herbert Wertheim College of Medicine, Florida International University, Miami, Florida. Electronic address: hsheha@northwell.edu.
Celso TelloDepartment of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York.
Lama A Al-AswadHarkness Eye Institute, Columbia University, New York, New York.
Mohamed S SayedBascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Richard K LeeBascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: rlee@med.miami.edu.
University of Miami · USColumbia University · USFlorida International University · USHofstra University · US

Funding

Shared Equipment ModuleP30EY014801 · NEI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI Dmitry V Ivanov · 2004 to 2026
$12.2M
Amniotic Membrane versus Pericardium in Reducing Glaucoma Drainage Tube ExposureR44EY019785 · NEI · TISSUETECH, INC. · PI EL SHEHA, HOSAM · 2012 to 2014
$997k
NEI NIH HHS P30 EY014801NEI NIH HHS R44 EY019785
6 · The paper itself

Abstract

purposeTo compare the long-term safety and efficacy of amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts in reducing glaucoma shunt tube exposure.

designMulticenter, prospective, randomized clinical trial.

participantsAdults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation.

methodsPatients were randomized to receive GDD with either AM-UC or pericardium patch grafts to cover GDD tubes. Patients were followed up clinically with anterior segment (AS) OCT to assess patch graft stability and host-tissue integration prospectively.

main outcome measuresTube exposure, graft thinning, and graft-related complications.

resultsA total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n = 72) or Ahmed valve (n = 9). Tubes were inserted in the anterior chamber (n = 71), sulcus (n = 6), or pars plana (n = 4). Tube ligation was performed with Baerveldt GDD along with fenestration (n = 51) or orphan trabeculectomy (n = 21). Tubes were covered with AM-UC (n = 41) or pericardium (n = 40). The mean follow-up time was 29±8 months (range, 13-40 months). Tube exposure occurred in 1 eye (2%) in the AM-UC group at 3 months and in 2 eyes (5%) in the pericardium group at 2 and 6 months (P = 0.54). Sequential AS OCT showed better host-tissue integration and significantly less graft thinning in the AM-UC group. Early graft thinning (≤3 months) occurred in 5 eyes (12%) in the AM-UC group and in 17 eyes (43%) in the pericardium group (P = 0.002). Late thinning occurred in 2 eyes (5%) and 11 eyes (28%) in the AM-UC and pericardium groups, respectively (P = 0.007). Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft. No evidence of graft rejection or infection was associated with the patch grafts in either group.

conclusionsAmniotic membrane-umbilical cord grafts are well tolerated and offer an alternative to pericardium for safe and stable tube shunt coverage. Its high-tensile strength, low immunogenicity, and excellent host-tissue integration significantly reduced graft thinning.

Indexed as

Glaucoma Drainage ImplantsVisual AcuityAdultAgedAged, 80 and overFemaleGlaucomaHumansIntraocular PressureMaleMiddle AgedProspective StudiesScleraTrabeculectomyYoung Adult

Identifiers

PMID32672570
PMCPMC7368089
OpenAlexW2967947336

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.