Complications Related to Implants Used in Anterior Bleb Forming Glaucoma Surgery: A Systematic Review of the Literature

Alejandra Salinas, Fabián Rodríguez, Javier Bardavío

Department of Ophthalmology, Hospital Universitario de Torrevieja, SpainSpain
Department of Ophthalmology, Hospital Verge de la Cinta,Tortosa, SpainSpain
St Mary’s Treatment Centre, Portsmouth, UKUnited Kingdom

DOI: https://doi.org/10.17140/ooj-3-118 · Published 2019-10-11 · Licence: https://creativecommons.org/licenses/by/4.0 · © 2019 The Author(s)

Also available as PDF (figures and tables appear in the PDF).

Keywords: Implant-related complications (IRC); Glaucoma surgery; Anterior bleb forming

Methods

A systematic search of Pubmed and Scopus databases and Google Scholar engine was performed with selection criteria to detect

papers on IRC. We excluded unrelated papers and reviewed selected ones. We considered papers that did not explicitly state about

occurrence or not occurrence of IRC as non-IRC reporting. Main outcome measures were the number of papers reporting on

complications, IRC, and types of IRC.

Results

After the search, selection, and addition, we studied 109 papers.

26 implant studies found IRCs (23%), 13 case reports on surgical complications, 8 (61.5%) of them reported IRC. Frequent

complications were conjunctival erosion, blockage of the tube, migration to anterior chamber or damage to surrounding tissues.

Conclusion

Most papers did not report on IRC. Length or nature of studies

and sharp implants carry a greater risk of IRC and explantation.

Keywords

Implant-related complications (IRC); Glaucoma surgery; Anterior bleb forming.

Introduction

laucoma is a chronic progressive optic neuropathy that may

cause severe visual loss and affect the quality of life. The G front line of treatment consists of reducing intraocular pressure.

Most patients achieve good medical control: some require one or

more surgical procedures. Although conventional filtering surgery

is effective has only moderate success and are subject to risks.

Some devices have been designed and introduced to improve suc-

cess and risks. Some of these implants are associated with classical

conventional fistulizing surgery or to newer filtering procedures

cc Copyright 2019 by SalinasA. This is an open-access article distributed under Creative Commons Attribution 4.0 International License (CC BY 4.0), which allows Incidence of IRC was 4.5%, half required explantation. While

may skew finding IRC. The incidence of IRC was 4.5%. Hard

that intend the construction of a paralimbal bleb (subconjuncti-

val, Subtenon’s or intra-scleral). Regulatory bodies have studied

the security and effectiveness of these implants and authorized

for human application. Some systematic reviews or meta-analysis 1-4 show that support for the use of these devices may be limitated.

This study aimed to make an account of published implant-related

complications (IRC), this is complications directly caused by the

implant, by a systematic review of the literature up to April 2015.

Only implants that contribute to creating a paralimbal bleb were

considered since those are the ones that are used as an alternative

to trabeculectomy or non-penetrating deep sclerectomy and are

potentially avoidable. We excluded equator bleb creating implants,

angular devices or anterior chamber to supraciliary space shunts

from the scope of this study. We were also interested to know

how many of the papers referred to complications related to the

implants.

Methods

Search Strategy

Three different search engines were used: Pubmed, Google Schol-

ar and Scopus in April 2015. The search was performed over all

fields of bibliographic references. We applied three levels of search

restriction and combined controlled Mesh and natural languages.

Language filters were applied. Inclusion criteria: any series of pa-

tients, whether prospective or retrospective and case reports in

English, Spanish or French (filtered) found introducing the se-

lected keywords. The word “complication” was extended to the

abstract search also. Exclusion criteria: reports on other glaucoma

Table 1. Search Strategy Details

# Searches on Google Scholar Results

((implant* OR collagen implant OR collagen implants OR “Hemacrylic Metha bar”) AND complication) AND (glaucoma)

(implant* OR esnoper OR skgel OR aquaflow OR “ex-press” OR “collagen implant” OR “collagen implants” OR “Hemacrylic” OR “reticulated 2 hyaluronic acid” OR “T flux” OR “T bar”) AND complication* AND Glaucoma-“Molteno Implants”-Molteno-Ahmed-“Krupin valve”-“krupin 2300 valves”-Baerveldt)

(“Filtering Surgery” OR “Trabeculectomy” OR “Filtering Surgeries” OR OR “deep sclerectomy” OR “Sclerostomy” OR “deep sclerectomies” OR viscocanalostomy) AND (implant* OR esnoper OR skgel OR aquaflow OR “ex-press” OR “collagen implant” OR “collagen implants” OR “Hemacrylic” OR “reticulated hyaluronic acid” OR “T flux” OR “T bar”) AND complication* AND Glaucoma-“Molteno Implants”-Molteno- Ahmed-“Krupin valve”-“krupin valves”-Baerveldt)

# Searches on Scopus

(TITLE(implant* OR esnoper OR sk gel OR aqua flow OR “express implant*” OR “collagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR “T flux” OR “T bar”) OR ABS(implant* OR esnoper OR sk gel OR aqua flow OR “express implant*” OR 4 “collagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR “T flux” OR “T bar”)) AND (TITLE(complication*) 1533 ORABS(complication*)) AND (TITLE(glaucoma) OR ABS(glaucoma)) AND (LIMIT-TO(LANGUAGE, “English”) OR LIMIT-TO(LANGUAGE, “French”) OR LIMIT-TO(LANGUAGE, “Spanish”))

(TITLE(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “collagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR“T flux” OR “T bar”) OR ABS(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “col- 5 lagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR“T flux” OR “T bar”)) AND (TITLE(complication*) OR 1106 ABS(complication*)) AND (TITLE(glaucoma) OR ABS(glaucoma)) AND NOT baerveldt) AND (LIMIT-TO(LANGUAGE,“English”) OR LIMIT-TO(LANGUAGE,“French”) OR LIMIT-TO(LANGUAGE,“Spanish”))

(TITLE(“Trabeculectom*” OR “Filtering Surger*” OR “deep sclerectom*” OR “Sclerostomy” OR viscocanalostom*) OR ABS(“Trabeculectom*” OR “Filtering Surger*” OR “deep sclerectom*” OR “Sclerostomy” OR viscocanalostom*)) AND (TITLE(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “collagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic 6 acid” OR“T flux” OR “T bar”) OR ABS(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “collagen implant*” OR 273 “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR“T flux” OR “T bar”)) AND (TITLE(complication*) OR ABS(complication*)) AND (TITLE(glaucoma) OR ABS(glaucoma)) AND NOT TITLE-ABS-KEY(Molteno* OR Ahmed OR“Krupin valve*” OR baerveldt) AND(LIMIT- TO(LANGUAGE, “English”)ORLIMIT-TO(LANGUAGE, “French”) OR LIMIT-TO(LANGUAGE, “Spanish”))

# Searches on Pubmed/Medline

(“Prostheses and Implants/complications”[Mesh] OR ((implant*[tiab] OR esnoper[tiab] OR skgel[tiab] OR aquaflow[tiab] OR “express implant”[tiab] OR “express implants”[tiab] OR “collagen implant”[tiab] OR “collagen implants”[tiab] OR “HemacrylicMetha Stealth”[tiab] OR “reticulated hyaluronic acid”[tiab] OR“T flux”[tiab] OR “T bar”[tiab]) AND complication*[tiab]))) AND (“Glaucoma”[Mesh] OR glaucoma*[tiab])

(TITLE(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “collagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR“T flux” OR “T bar”) OR ABS(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “col- 8 lagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR“T flux" OR “T bar”)) AND (TITLE(complication*) OR 967 ABS(complication*)) AND (TITLE(glaucoma) OR ABS(glaucoma)) AND NOT baerveldt) AND(LIMIT-TO(LANGUAGE, “English”) OR LIMIT-TO(LANGUAGE, “French”) OR LIMIT-TO(LANGUAGE, “Spanish”))

(TITLE(“Trabeculectom*” OR “Filtering Surger*” OR “deep sclerectom*” OR “Sclerostomy” OR viscocanalostom*) OR ABS(“Trabeculectom*” OR “Filtering Surger*” OR “deep sclerectom*” OR “Sclerostomy” OR viscocanalostom*)) AND (TITLE(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “collagen implant*” OR “Hemacrylic Metha Stealth” OR “reticulated hyaluronic acid” OR“T flux” OR “T 9 bar”) OR ABS(implant* OR esnoper OR skgel OR aquaflow OR “express implant*” OR “collagen implant*” OR “Hemacrylic Metha Stealth” 314 OR “reticulated hyaluronic acid” OR“T flux” OR “T bar”)) AND (TITLE(complication*) OR ABS(complication*)) AND (TITLE(glaucoma) OR ABS(glaucoma)) AND NOT TITLE-ABS-KEY(Molteno* OR Ahmed OR“Krupin valve*” OR baerveldt) AND (LIMIT-TO(LANGUAGE, “English”) ORLIMIT-TO(LANGUAGE, “French”)ORLIMIT-TO(LANGUAGE, “Spanish”)) drainage devices like Ahmed or Krupin Valve, Baerveltd or Mol-

teno drainage devices. Any anterior chamber to supraciliary or su-

prachoroidal shunts like Gold Micro Shunt or Esnoper V-2000. Pa-

pers in any other languages. Keywords: “prostheses and implants/

complications”, “glaucoma drainage implants”, implant, ex-press,

esnoper, SK gel, aqua flow, collagen implant, Hem Acrylic, reticu-

lated hyaluronic acid, T flux, thiobarbituric acid-reactive (T BAR),

filtering surgery, filtering surgeries,deep sclerectomy, non-penetrat-

ing deep sclerectomy, viscocalanostomy, trabeculectomy, scleros-

tomy. Mendeley reference manager (www.mendeley.com,5 Elsevier)

detected duplications. Refer to Table 1 for search strategy.

Initial Revision Strategy:The Selection of Papers for Revision

All papers’ titles were reviewed by a team of trained or in training

ophthalmologist in search of papers that reported on paralimbal

bleb forming surgical procedures with the implantation of a de-

vice. When in doubt, we reviewed the abstract. We excluded papers

reporting on surgical procedures without an implant, different pro-

Stealth” OR “reticulated hyaluronic acid” OR “T flux” OR “T 11600

1572

TITLE-ABS-KEY(Molteno* OR Ahmed OR“Krupin valve*” OR

1249

TITLE-ABS-KEY(Molteno* OR Ahmed OR“Krupin valve*” OR

cedures all together (posterior forming blebs, angular surgery, an-

terior chamber to supraciliary or suprachoroidal shunts), different

languages or animal studies. We included systematic reviews and

meta-analysis of implanting surgical procedures studies to secure

relevant studies that our search could have missed out, but care-

fully made sure we did not duplicate the study papers by doing so.

Full text of all included papers was requested for revi-

sion. New references were found during revision and added under

the same criteria.

Ethical Committee approval was not requested as no pa-

tient information was searched at any time.

Outcome Measures

The following outcomes were measured: total number of papers

after exclusions, number of papers that report complications, num-

ber of papers that report IRC, type of implant, type of IRC found

as extrusion, migration, damage to surrounding tissue, dysfunc-

tional implants, explanted cases, relocated cases, other (Table 2).

Table 2. Definition of Outcomes to be Measured

Outcomes to be Measured

• Number of papers found once the non-related are excluded • Number of papers that report complications • Number of papers that report implant-related complications • Type of implant-related complications found with every implant o Extrusion o Migration o Damage of surrounding tissue o Obstructed o Explanted cases o Relocated cases o Other

Papers’revision was directed to find a statement on com-

plications within the method and the results sections of the ar-

ticle. We did not look for complications reports within the dis-

Figure 1. Final Number of Papers Considered for Study Purposes cussion section nor conclusions of the papers. Since the presence or absence of complications report is not interpretable, only one reviewer read through every paper. A paper was considered to re- port on IRC if the actual complication was reported or it explicitly stated that no IRC was found during the study. Papers that did not

state one thing or the other were considered not to report on IRC.

In case of doubt, the paper was consulted with the senior ophthal-

mologist in the study group.

A register of complications was established to include

both studies with and without complications’ reports.

Results

The result from the search of the three engines was 253 papers

from Scopus, 314 from Pubmed and 1572 from Google Scholar

that were reduced to 1102 after removing redundant papers. All ti-

tles of those papers were reviewed to discard unrelated ones when

in doubt the abstract was used. Finally, 120 full-text articles were

requested for review. From systematic revisions and meta-analysis,

we found 28 new unknown references that were also requested.

From a total of 148 papers, 23 were excluded due to belonging to

animal or experimental implants studies, reporting on the different

procedure, German language, or unfound full text. Of the 125 reviewed papers, 9 were systematic reviews, and 7 were meta-analysis 1-16 that included studies already reviewed by this research team.

Therefore, the final number of papers considered for study pur- 17-126 poses was 109 (Figure 1).

All these papers correspond to studies or case reports that

report on glaucoma implant surgery and also on surgical complica-

tions (100% of the 109 papers reviewed). Out of the 109 papers reviewed, 75 (68.8%) did not report on IRC, 34 (31.2%) reported

on IRC, 6 (17.6%) of the IRC reporting papers) explicitly report-

ing an absence of IRC (4 prospective and 2 retrospective studies).

Of the 59 prospective studies (54.1%, of 109), 17 reported on IRC

(28.8%, of 59). Of the 37 retrospective studies (33.9%, of 109), 9

(24.3%, of 37) reported IRC. Thirteen of the papers (11.9%, of

Table 3. Understudy Implants, IRC Reporting Papers, Number of Study Eyes (Eyes with Implants in IRC Reporting Papers) and Number of Complicated Cases

Implant Nº of Papers* Nº IRC Papers** Nº of Study Eyes Nº Complicated Cases

Express (Steel) 38 22 (57,9%) 940 54 (5,7%)

Collagen Implant 25 5 (16,6%) 208 9 (4,3%)

SK-gel (Hyualuronic acid) 25 3 (12%) 185 2 (1,07%)

T-flux (Acrylic) 15 1 (7,14%) 25 1 (4%)

Ethicon 1/0 Chromic Catgut 1 1 (100%) 23 1 (4,3%)

PMMA 1 1

ePTFE 1 1

Ologen (Collagen) 9 1

HEALA Flow 1 0

Aquaflow (Collagen) 5 0

Total 109 35

*Twelve papers tested two or three implant devices; **One paper tested two devices PMMA and Collagen implant

Table 4. Reported Complications

Implant Complication

Migration or 1 migration to malposition subconjunctival space

1 conjunctival erosion and extrusion that did Extrusion not require explants or repositioning

Damage to 1 Corneal abrasion surrounding 5 Descemet mb.

tissues detachment

Obstructed

Explanted During hypotony

Explanted as treatment of complication

Repositioned

109) were case reports, 8 (61.5%, of 13) reported IRC.

The total population of eyes considered in this study was

5831 (population range per study: 1-345), 4576 of which had been

implanted (78.4%), the others belonging to control groups. The

population of eyes with an implant included in studies that report-

ed on IRC was 1479. Of those, the number of eyes that suffered

an IRC was 67 (4.5%). Table 3 shows the implants understudied,

the number of IRC reporting papers, the number of study eyes

and the number of complicated cases.

A summary of the complications is in Table 4. The most

common IRC was conjunctival erosion; 20 cases after Express im-

plantation (15 through a full-thickness scleral incision, four under 30 0

35 0

33 0

0 0

0 0

1479 67 (4,5%)

Ethicon 1/0 chromic SK-gel Collagen Implant T-flux Express catgut

1 misplacement 1 migration 1 into anterior 1 migration to subconjunctival into anterior chamber after blunt space chamber trauma 5 into anterior chamber

20 conjunctiva erosions (15 without scleral flap,4 with sclera flap,1 unknown)

5 iris touch 2 endothelial touch 1 Corneal abrasion 1 crystalline lens touch 1 scleral flap erosion only

2 unreported reasons 1 due to infection repair surgery

3 relocated due to other complication Other causes

a partial-thickness scleral flap and one unreported technique) that

required implant removal, and one case of SK-gel that healed un-

der observation. Obstruction of Express tube occurred in 14 cas-

es. Four Express tubes migrated postoperatively into the anterior

chamber (AC) and another one was introduced in the AC during

the procedure. Another Express tube migrated to the subconjunc-

tival space, as it occurred to an SK gel implant, and a further Ex-

press tube was found misplaced. A T flux implant migrated into

the patient’s anterior chamber. A fragment of Ethicon 1/0 chromic

catgut, placed under a deep sclerectomy flap, migrated into de AC

also. Sixteen cases of damage to surrounding tissues were found, 5

Descemet membrane detachments and one corneal abrasion after

collagen implant, five iris touch, two endothelial touches, one cor-

neal abrasion, one crystalline lens touch that induced a white cata-

ract and one scleral flap extrusion, without conjunctival erosion,

after Express implantation. Three primary explantation of Express

tubes, one due to a bleb infection and two for unreported reasons,

as well as three collagen implant removal during the hypotony re-

pair. A total of 29 Express tubes (3% of all tubes implanted) and

three collagen implants (1.4% of all implanted) were explanted.

Discussion

The market offers implants in an attempt to improve post-operative

survival, efficacy or safety for patients requiring glaucoma surgery.

Some studies, however, suggest that traditional trabeculectomy or

newer deep sclerectomy without implants might be just as effective

in reducing intraocular pressure. Devices, therefore, attempt to im-

prove prognosis, but its mere physical presence may also increase

risks. This study aimed to make an account of published IRC by a

systematic review of the literature up to April 2015. We only stud-

ied implants that contribute to creating a paralimbal bleb. Equator

bleb creating implants, angular devices or anterior chamber to su-

praciliary space shunts are not within the scope of this study.

Our search produced a total of 1102 papers. The use of

natural language and mesh terms explain such a large number of

papers found. The initial selection resulted in 120 papers of which

23 were further excluded, and another 28 were added during revi-

sion. Seven systematic reviews, nine meta-analysis, 13 case reports,

37 retrospective and 59 prospective studies were reviewed. Only

an explicit account of IRC was considered as a report. All papers

reviewed (109/109) reported surgical complications. Only 31.2%

reported on IRC: 6 (17.6%) of those (4 prospective and two ret-

rospectives), reported an absence of IRC. Only 28.8% of all pro-

spective and 24.4% of all retrospective studies reported on IRC.

It was therefore interesting to find that of 13 case reports dealing

with complications, 8 (61.5%) were about IRC. We suspect that the

discrepancy in IRC incidence reported in retrospective and pro-

spective studies compared to case reports might be related to the

length of the studies and although inconclusive, could be relevant.

Issues related to reporting could justify further research.

Sixty-seven cases of IRC of 1479 (4.5%) patients were

found, of which 31 required implant removal. Our estimation

of IRC incidence might be biased by the search or the selection

method. The incidence of Express removal was 3% before the

tube was guarded under a scleral flap: that reduced the risk but did

not eliminate it. The initial design of the technique may show that

the risk of extrusion was underestimated. Risk of misplacement

or injury to surrounding tissues like Descemet membrane, corneal

endothelium or the crystalline lens is also relevant as well as migra-

tion into the anterior chamber of mainly the express tubes.

The physical properties of the implant are relevant: hard-

er and sharper implants that remain longer, increase the risk of

complications, mainly extrusion. In our study, the steel implant Ex-

press accounts for most cases of explanted, extruded or migrated

cases. Also, non-absorbable acrylic T flux tends to migrate if left

unfixed. Soft and absorbable implants tend to be more respect-

ful. We speculated that tensile vectors generated by scaring tissue might tend to move rigid pieces and to fold soft material: this could

explain the migration of implants or simple orientation changes.

The intermittent robbing effect of the eyelid over the conjunctiva

exerts an external pressure (tissue towards implant) that injures the

tissue in the opposite direction (implant towards sclera, conjunc-

tiva or both). Both mechanisms are active in all operated eyes, so

the risk to induce complications exists.

Study limitations include missing relevant papers by the

search (no excerpta medica dataBASE (EMBASE) search) or the

selection method: the initial search failed to detect 28 relevant pa-

pers added later. It is possible that relevant data from studies was

filtered out by title or abstract selection. A further limitation is late

publication of this study that was finalized in 2016 and sent for

publication in 2019. Finally, this review relies on what authors re-

port on their papers, under or overreporting issues would modify

these results. However, the study remains useful to stress the fact

that an implant might induce complications by itself. Also, the type

and shape of the material are relevant and worth bearing in mind

at the time of assessing the purpose and usefulness of the implant.

Further, the importance of considering IRC at the time of design-

ing studies to make them sensible to complication detection and

reporting.

Conclusion

An IRC incidence of 4.5% resulted from this study, of which

about a half required removal. Harder and sharper implants carry

a higher risk. It is worth considering the implant’s function and

the risk it may carry its implantation before making the clinical

decision of using them. Studies should consider this risk and be

methodologically designed to detect them.

Acknowledgements

The authors are thankful to Ms. Noemi Aluja for her contribution

towords the bibliography.

Conflicts Of Interest

The authors declare that they have no conflicts of interest.

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