Br J Ophthalmol-1999-Mietz-814-21

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Risk factors for failures of trabeculectomiesperformed without antimetabolites

Holger Mietz, Birgit Raschka, Gnter K Krieglstein

AbstractAimsTo assess the risk profile for the

failure of trabeculectomies in a largegroup of patients who were selected to beoperated on without the use of antime-

tabolites. This was done in an eVort tofind subgroups of patients who may notneed antimetabolites for primary proce-

dures.MethodsConsecutive patients scheduledfor routine trabeculectomies were oper-

ated during a 4 year period and werefollowed up for at least 6 months postop-eratively. Patients were regularly exam-

ined in the glaucoma unit and by theirlocal ophthalmologists. Pre- and postop-erative data were evaluated and success

rates determined.Results709 eyes of 566 patients wereoperated on; 534 eyes of 534 patients

(94.4%) were finally evaluated. The meanfollow up was 27.9 (SD 13.6) months with arange of 662 months. Success rates for

complete surgical success ranged from59% in the best group with pigmentarydispersion syndrome to 0% in the worst

group with neovascular glaucoma. Suc-cess rates of patients with POAG, pseu-doexfoliation, chronic angle closure,pigmentary dispersion syndrome, anddysgenetic glaucoma were similar. Failurerates ranged from 11% in the best group(pseudoexfoliation) to 80% in the worstgroup (neovascular glaucoma). Failurerates were high in complicated forms ofglaucoma such as traumatic (30%), buph-thalmus (40%), and uveitic (50%). Forrepeat trabeculectomies, the failure ratewas 49% (20 of 41 eyes). The mean timeuntil failure ranged from 2.7 months(traumatic) to 15.5 months (pigmentarydispersion syndrome) and was 4.9 monthsfor repeat trabeculectomies.ConclusionTrabeculectomy performedin selected groups of patients has a

favourable outcome without the use ofantimetabolites. It may be possible toavoid antimetabolites in these groups ofpatients for primary procedures.(Br J Ophthalmol1999;83:814821)

Trabeculectomies performed according to thefirst description by Cairns1 2 or with slightmodifications are the most frequently per-formed surgical procedure in lowering theintraocular pressure (IOP). Failures of trab-eculectomies occur at a variable rate, and

reports about long term success rates of thisprocedure are diYcult to compare. At thepresent time, the advantage of the use of threediVerent drugs to inhibit fibrosis at theepiscleral level has been demonstrated inlarger clinical studies. These drugs includesteroids, 5-fluorouracil (5-FU) and mitomycinC (MMC). For the first two substances, datafrom 3 and 5 year follow up studies,respectively, with a prospective, randomiseddesign are available.3 4 There are several clini-cal studies showing the eYcacy and advantageof MMC for both complicated and uncompli-cated forms of glaucoma. While many of the

studies have no control group,510

some do.11 12

It may be accepted from clinical practice thatthe use of steroids has few side eVects, so ster-oids should probably not be restricted tocertain groups of patients. However, this maybe the case for the antiproliferative agents5-FU and MMC. An aspect from the mostrecent report of the 5-FU filtering study group4

is of interest. The use of 5-FU was recom-mended for the two subgroups which includedpseudophakic glaucoma and repeat trabeculec-tomies. For these groups, the reported successrates were markedly lower than in all otherstudies reported.13 14

Since there are only infrequent prospectivestudies available reporting the natural out-

comes of trabeculectomies for uncomplicatedcases of chronic open angle glaucoma,1522 it iseven more diYcult to determine which caseshave a higher risk for early or late failures thanothers. At a time where diVerent treatments forenhancing the outcome of trabeculectomiesare available, there is a need to obtaininformation on which risk factors are impor-tant and what risk of possible side eVects canbe tolerated.

Since the introduction of the routine use ofMMC in our department, we followed pro-spectively the outcome of all trabeculectomies.Eyes with a higher risk for failure and eyes withsecondary forms of glaucoma were operated on

with MMC, while eyes with open angleglaucoma and when serious side eVects ofMMC were feared, were operated on withoutthe use of MMC. We did not use 5-FU orMolteno implants. In this communication, wereport the follow up on all cases where noMMC was used in order to determine the suc-cess rates of cases of uncomplicated and com-plicated glaucoma from a large group ofpatients.

Materials and methodsWe evaluated the preoperative data, course,and outcome of all trabeculectomies per-

Br J Ophthalmol1999;83:814821814

Department ofOphthalmology,University of Cologne,Cologne, Germany

H MietzB RaschkaG K Krieglstein

Correspondence to:H Mietz, MD, Departmentof Ophthalmology,University of Cologne, 50924Koeln, Germany.

Accepted for publication1 March 1999

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formed without MMC that were operated onby our department between January 1992 andDecember 1995. Informed consent was ob-tained from all patients before surgery. Thelocation of all charts was monitored using acomputerised system.

Patients were followed up by our glaucomaunit and/or their local ophthalmologists. Pre-operative data included the type of glaucoma,the duration of the disease, the current andprevious medications, current and previousintraocular pressure, visual acuity, and otherocular abnormalities. The computerised visualfield tests (Humphrey field analyser, program

30-2) were obtained and repeated regularly.Patients were only eligible for the study whentypical glaucomatous field defects werepresent. Intraocular pressures without medi-cation were greater than 21 mm Hg in all cases.No cases of low tension glaucoma wereincluded.

The visual field examinations were notanalysed statistically since some ophthalmolo-gists use diVerent programs. Cataract progres-

sion had an influence on the field tests, whichmakes it diYcult to assess them objectively.The data from the visual field testing were usedand were helpful in assessing the progression ofglaucoma. Follow up information includedcurrent medications, visual acuity, intraocularpressure, ocular abnormalities, surgically re-lated complications, and the need for furthersurgical procedures.

For statistical evaluation, we used the data ofeach patient from the last complete ocularexamination performed either in our depart-ment or by their local ophthalmologist. Toavoid bias, only the eye operated first wasevaluated from patients where both eyes were

operated with suYcient data available. Thisreduced the total number of eyes in the studyconsiderably, but was done in an eVort toimprove the statistical power of the results.

The success rate was judged using frequentlyused definitions.3 4 8 1 0 Complete success wasdefined as an IOP of less than or equal to 21mm Hg without antiglaucomatous medication;qualified success as an IOP of less than orequal to 21 mm Hg with antiglaucomatousmedication. For both groups, the visual fieldhad to be stable except for increasing defectsthat were not related to glaucoma. In addition,the cup/disc ratio should not have any progres-sion along the course of the follow up period.

Failures were defined as an IOP of greaterthan 21 mm Hg under medication, progressiveglaucomatous visual field loss combined withan increase of cupping of the optic disc regard-less of the IOP, or the need for furtherantiglaucomatous surgical procedures.

In some patients, data from the Heidelbergretina tomograph (HRT, Heidelberg Engineer-ing, Germany) were available and the infor-mation was thus used in monitoring theprogression of the disease in concert with theabove criteria.

For statistical analysis, the Wilcoxon logrank test was used in order to determinesignificant diVerences of visual acuities, IOP

Table 1 Study population

Characteristics n (%)

Number of eyes operated 709 (100.0)Number of patients 566 (100.0)

charts not found 17 (3.1)follow up less than 6 months 15 (2. 7)

Remaining eyes 670 (94.3)Remaining patients 534 (94.4)Pa ti en ts o pe rat ed o n b ot h ey es 13 6 ( 24 .0 )Eyes included in this study 534Follow up of all 534 eyes

mean (SEM) (months) 27.9 (0.60)range (months) 661

Table 2 Characteristics and diagnoses of patients

CharacteristicsNo of eyesn (%)

Number of eyes 534 (100)Number of patients 534Sex/age (years)

M al e ( mea n (S D) ) 5 7. 3 ( 20. 2)range 2 weeks88 years

Female (mean (SD)) 62.2 (18.5)range 2 weeks91 years

RaceWhite 534 (100)

Sex

Female 258 (48)Male 276 (52)

Type of glaucomaprimary open angle 209 (39.1)pseudoexfoliation 117 (21.9)chronic angle closure 47 (8.8)pigmentary dispersion

syndrome 34 (6.4)buphthalmus 25 (4.7)dysgenetic glaucoma 21 (4.0)uveitic glaucoma 14 (2.7)traumatic 10 (1.9)neovascular glaucoma 5 (0.9)steroid induced 3 (0.5)malignant glaucoma 3 (0.5)pseudophakic glaucoma 2 (0.3)aniridia 2 (0.3)

Repeat trabeculectomy 41 (7.9)

Table 3 Data of the diVerent groups operated

DiagnosisMean age at diagnosisof glaucoma (years)

Mean age atsurgery (years)

Follow up(months)*

Time until failure(months)*

Rate of failure(%)

Primary open angle 57.9 65.7 28.7 (0.9) 13.0 (2.4) 15.0Pseudoexfoliation 63.5 69.2 29.5 (1.3) 1 1.2 (2.3) 11.2Chronic angle closure 56.2 63.6 29.3 (2.0) 8.7 (4.9) 12.8Pigmentary dispersion syndrome 42.1 48.9 27.5 (2.5) 15.5 (7.6) 17.6Buphthalmus 0.1 3.5 21.9 (2.8) 3.6 (1.0) 40.0Dysgenetic glaucoma 39.6 43.1 24.9 (2.5) 10.6 (3.1) 23.8Uveitic glaucoma 48.3 55.8 27.8 (3.0) 8.6 (3.2) 50.0Traumatic 37.8 47.2 26.9 (4.1) 2.7 (1.2) 30.0Neovascular glaucoma 62.3 64.6 31.0 (6.8) 12.5 (6.4) 80.0Repeat trabeculectomy 32.0 47.2 24.7 (2.5) 4.9 (1.2) 48.8

*Mean (SEM).

Trabeculectomy and r isk factors 815



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values, and the amount of medications be-tween two examinations within the groups ofpatients. The Wilcoxon log rank test was alsoused in comparing diVerent aspects betweenpatients with a complete surgical success withthose that failed. A statistically significantdiVerence was assumed for p values lower than0.05. KaplanMeier life table analysis was usedto assess survival curves.

For further evaluation and statistical analysis(Tables 3, 4, 5) only such groups that includedsix or more eyes were evaluated. For the directassessment of risk factors for failure, only eyeswith POAG, pseudoexfoliation, and repeattrabeculectomies were evaluated (Tables 6, 7,8), since these groups were large enough toobtain profound statistical data.

IOP was measured using Goldmann appla-nation tonometry. In cases with major cornealor axial and scleral abnormalities, such asbuphthalmus, Perkins applanation tonometrywas used. In each individual case, the sametechnique was applied in preoperative andfollow up measurements. To determine the

number of medications used each topicalmedication was counted as one, if used accord-ing to the manufacturers recommendation.Systemic treatment with carboanhydrase in-hibitors counted as one point. Cases in whichthe maximum tolerable doses were used (threetimes 250 mg) counted as two points.

Visual acuities were taken using ETDRScharts and transformed into logMAR data forcalculation and then retransformed into

decimals.23

ResultsWe examined a total of 709 cases from 566patients who were operated on betweenJanuary 1992 and December 1995. Of these709 trabeculectomies, we were unable to locateinformation from 23 (3.3%) eyes from 17(3.1%) patients (Table 1). All cases in whichthe follow up was less than 6 months wereexcluded from the evaluation. Cases with a fol-low up of less than 6 months included 16(2.3%) eyes from 15 (2.8%) patients. Reasonsfor short follow up were: patients who failed toappear in the department or their localophthalmologist and so could not be moni-tored (n=10); patients who had emigrated(n=3); or patients who died (n=2). This left670 eyes of 534 patients for evaluation.

A total of 276 men and 258 women wereoperated on. The mean age at the time of sur-gery of the men was 57.3 years and the meanage of the women was 62.2 years (Table 2).There was a statistical diVerence in the age dis-tribution between these two groups (p


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less frequent. In 48 cases (7.9%), a repeat trab-eculectomy was performed. Many of thesepatients had a diagnosis of buphthalmus(33%).

The mean age of the patients at which thediagnosis of glaucoma was made was earliest inthose with buphthalmus; in many of which thediagnosis was established at or soon after birth(Table 3). In patients with trauma anddysgenetic glaucoma, the diagnosis was estab-lished relatively early with a mean age of 37.8

and 39.6 years, respectively. Patients withPOAG and pseudoexfoliation tended to besomewhat older with a mean age of 57.9 and63.5 years, respectively. The mean intervalbetween diagnosis and surgery was 7.8 yearsfor the patients with POAG, 5.7 years for thosewith pseudoexfoliation, and 7.4 for patientswith chronic angle closure. This interval wasshorter in patients with buphthalmus (3.4years). Newborns with the diagnosis of buph-thalmus were usually operated on within a fewweeks or months, but some individuals withbuphthalmus were presented at a later stage ofthe disease. In patients with neovascularglaucoma, the interval was 2.3 years.

The mean follow up exceeded 20 months inall groups, with 31.0 months for eyes with neo-vascular glaucoma being the longest. The timeuntil failure was short in eyes with trauma(mean 2.7 months), buphthalmus (mean 3.6months), repeat trabeculectomy (mean 4.7months), and longer in those with POAG(mean 13.3 months) and pigmentary disper-sion syndrome (mean 15.5 months). The aver-age time until failure of the trabeculectomy wasnot diVerent among the four groupsPOAG,pseudoexfoliation, chronic angle closure, pig-mentary dispersion syndrome, and dysgeneticglaucoma (p


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laser trabeculoplasty (ALT) did not seem tohave any influence.

In eyes with pseudoexfoliation (Table 7),previous cataract surgery also was found to bea risk factor. It appeared for eyes with repeattrabeculectomies that failures tended to be

younger than their successful counterparts(Table 8), they were predominantly male, andhad undergone previous goniotomy. This maybe caused by the fact that this group includes alarge number of eyes with buphthalmus. Therate of previous cataract surgery was not diVer-ent among the groups.

DiscussionIn this study, we have shown that the interme-

diate term results of trabeculectomies per-formed without the supplemental use ofantimetabolites may have good results inselected cases. Variables that influenced thesuccess rates included, mostly, the type ofglaucoma. In subgroups the age, sex, and pre-vious surgery such as goniotomy and cataractsurgery were also important factors. Thenumber of eyes in this report with suYcientfollow up was relatively high at 94.3% This isconsiderably higher than in most clinical stud-ies presented on this topic so far. The surgicalskills of one or only a few surgeons had no largeimpact, since the procedures were performedby several diVerent glaucoma surgeons during

a 4 year period.In previous years, intermediate term andlong term results of trabeculectomies wererelayed for both selected and unselectedgroups of patients at a time when few surgicalalternatives such as the use of 5-fluorouraciland MMC, trans-scleral laser therapy, visco-canalostomy, or Molteno implants wereavailable.1517 2428 More recently, various studiesfocused on the issue of the use of MMC forprimary procedures.5 29 30 In those reports thesuccess rates for MMC operated eyes and con-trols varied widely.5 29 These results reflect thefact that patient selection is a crucial factor inclinical studies even when the studies are wellexecuted.

The high success rate of trabeculectomies inpatients with POAG has been repeatedlynoted. Cairns2 in his early report in 1972 had asuccessful outcome in 78 of 80 eyes (97.5%).DErmo et al 24 found in a follow up study from1 to 5 years a success rate of 71%. In anotherretrospective long term follow up study,25 asuccess rate of 87% was reported in a total of220 eyes with POAG and a follow up of up to 7years. In a smaller study, Lewis and Phelps 31

noted only a 65% success rate of trabeculecto-mies in eyes with POAG followed up for 5years. Wilson32 reported a 7 year follow upstudy of 309 eyes with a success rate of 85%.Inaba33 studied the outcome of trabeculectomy

in 427 eyes in the Japanese population and hadan overall success rate of 75%.It has been repeatedly and most convincingly

shown that antimetabolites are beneficial forcases with complicated forms of glaucoma.7 9 3436 However, the discussion atthis time questions those cases that have fewerrisk factors for the failure of trabeculectomy.Knowing about the sometimes deleterious sideeVects of the use of 5-FU or MMC,3743 it maybe necessary to re-evaluate risk factors in thefailures of trabeculectomies and in describinggroups of patients who have a low risk for thefailure of primary procedures. On the other

Figure 1 (A) Probability of surgical success in the subgroups with POAG,pseudoexfoliation, chronic angle closure, and pigmentary dispersion. The KaplanMeiersurvival plots showed no significant diVerence (p=0.45, log rank test). (B) Probability ofsurgical success in the subgroups with traumatic, uveitic, and neovascular glaucoma. The

KaplanMeier survival plots showed no significant diVerence (p=0.30, log rank test). (C)Probability of surgical success in the subgroups with dysgenetic glaucoma, buphthalmus, andrepeat trabeculectomies. The KaplanMeier survival plots showed a significant diVerence(p=0.017, log rank test).

1.0

0.8

0.4

0.6

0.2

0

6040 50

Months

A

Survival

30200 10

POAG

pseudoexfoliation

chronic angle closure

pigmentary dispersion

1.0

0.8

0.4

0.6

0.2

0

6040 50

Months

B

Survival

30200 10

traumatic

uveitic

neovascular

1.0

0.8

0.4

0.6

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0

6040 50

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C

Survival

30200 10

dysgenetic

buphthalmus

repeat trabeculectomy

818 Mietz, Raschka, Krieglstein



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hand, it is also important to follow up patientswith a presumed high risk for failure who were,for various reasons, operated on withoutantimetabolites in order to investigate theiroutcome.

The current study was possible because weused few therapeutic alternatives other thantrabeculectomies during this time in ourdepartment. Trabeculectomies were per-formed either with or without MMC, and no

5-FU or Molteno implants were employed. Itwas therefore possible to study a large, hetero-geneous group of patients who could avoid theuse of MMC. Therefore, the results of thisevaluation may serve to re-evaluate clinicallyimportant decisions.

Kupin et al29 studied the success of trab-eculectomies performed with or withoutMMC in eyes with POAG. With a follow up of12 months, the success rates were 85% forMMC operated eyes compared with 56% forthe controls. It is unclear why the controls hadsuch unfavourable results when compared withour patients with POAG who had a failure rateof only 16%. Costa et al 42 performed a similar

study and again had a low success rate inPOAG eyes that were operated without MMCwith only 29% after a mean follow up of 16months. Given the high success rates fortrabeculectomy in such eyes in the presentreport, it is diYcult to understand why the suc-cess rates were so diVerent, and why MMC,which has a higher rate of complication, shouldbe used in primary procedures in such cases.

Interestingly, in our study success rates werealmost similar in eyes with POAG, pseudoexfo-liation, and chronic angle closure. A similarresult was found in a study in which successrates in younger individuals were evaluated. 44

Risk factors with statistical significance in thatinvestigation included previous cataract sur-

gery, ALT, previous glaucoma surgery, andIOP larger than 40 mm Hg. Patients with dys-genetic glaucoma were significantly youngerthan those with POAG in our study, andsuccess and failure rates were almost identical,so that we can support the finding from thatstudy44 that the age alone is not a general riskfactor.

The best therapeutic approach for eyes withcongenital glaucoma or buphthalmus is stillcontroversial. While some authors report highsuccess rates for trabeculotomy,16 45 this proce-dure is not performed exclusively. At thecurrent time, some glaucoma surgeons tend tofavour trabeculectomies in those eyes as

well.

20 46 47

In general, treatment is diY

cult, andthe average number of surgeries in controllingthe IOP in this group is around three.48 49 Suc-cess rates range from 35% in one study50 to92%.51 Because of the young age of the patientsand its unknown long term side eVects MMCis not yet generally acceptable in such cases.This was also the reason why our youngerpatients were operated on without MMC.

The results of the treatment of neovascularglaucoma with trabeculectomy again varywidely. In one report a success rate of 67% wasdescribed.28 In a subgroup of the pilot study for5-FU,36 eyes were even operated on with the

adjunctive use of 5-FU, and the 5 year successrate was only 28%. In that report, the mediansurvival time was 39 months. In our study, themean time until failure was 12.5 months with ahigh failure rate of 80%. It may be appropriateto use MMC primarily in those cases toimprove the success rate of the first surgicalintervention.

Uveitic glaucoma is a secondary form ofglaucoma, which is usually associated with a

poor prognosis for filtering procedures. It maybe that certain factors within the aqueoushumour in those eyes influence or acceleratethe wound healing response at the subconjunc-tival and episcleral level.52 Both Patitsas et al35

and Jampel et al53 operated on eyes with uveiticglaucoma with the aid of 5-FU. In the firststudy, 71% of the eyes were controlled after amean follow up of 34 months, while in the lat-ter the IOP was controlled in all 12 eyes. Themean 5-FU dosage was 58 mg and 33 mg,respectively. Prata et al34 used MMC with aconcentration of 0.2 mg/ml and 0.5 mg/ml.From 24 cases operated 18 (75%) werecontrolled after a mean follow up of 9.8

months. All failures were operated with thelower concentration of 0.2 mg/ml. In our study,a complete surgical success was only achievedin 36% of the cases, while the mean follow upwas 28 months. It seems that the supplementa-tion of trabeculectomies with antimetabolitesserves to obtain markedly better results in thisgroup of patients.

Eyes with one failed filtering procedure areobviously at high risk for consecutive similarsurgical procedures. It is interesting that in thewell executed, long term follow up 5-FU study4

it was stated that caution should be exercisedin the use of 5-FU in cases that usually have agood prognosis. In contrast with that report,Goldenfeld et al 54 used 5-FU in primary

procedures on patients with POAG. The aver-age follow up time was 20 months, and thesuccess rate of the 5-FU operated eyes was94% compared with 73% in the controls. Suc-cess was defined as an IOP of less than 21 mmHg regardless of the need of antiglaucomatousmedication.

The influence of chronic topical antiglauco-matous therapy on the outcome of filteringsurgical procedures has long been noted.Lamping et al55 retrospectively studied the out-come of 252 eyes with either full thickness pro-cedures or trabeculectomies that hadundergone surgery without previous topicaltherapy. The 4 year success rate for trabeculec-

tomies was 76%, not much diV

erent from ourpatients with previous topical therapy. Johnsonet al56 studied a total of 150 eyes that had ornot had a history of long term medical therapywith blockers and found no diVerence in thesuccess rates between eyes of the two diVerentgroups. Broadway et al57 performed a similarstudy and revealed that the use of blockersbefore surgery did not change the outcome sig-nificantly. However, the additional use of miot-ics and/or sympathomimetics did reduce thesuccess rates. The increasing number of previ-ous topical medications was associated with anincrease of pale cells, macrophages, and




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lymphocytes in the superficial conjunctival lay-ers. In the current study, we were unable toreveal a significant diVerence in topicallyapplied medications when we compared thetwo groups with complete success and failures.

The influence of ALT on the success of trab-eculectomies has been discussed in the past.Spaeth and Baetz58 found in a large, prospec-tive study that ALT controls the IOP in 33% ofthe cases for 5 years. Johnson et al56 showed

that eyes with a history of previous ALT had alower success rate following trabeculectomyafter 1 year with 75% versus 91%. In our study,we did not find that those eyes with previousALT were significantly more often associatedwith failures (Table 7).

In summary, we have shown that in the erawhere powerful antifibrotic agents are availablefor immediate use to the glaucoma surgeon, itis worthwhile analysing the risk profile of eachcase in order to determine whether their usemay be beneficial or necessary. In selectedgroups of patients with POAG, pseudoexfolia-tion, chronic angle closure, and dysgeneticglaucoma, success rates are encouragingly high

without the use of any additional substances.Success rates were well below 50% in othergroups of secondary glaucoma such as repeattrabeculectomies, uveitic, traumatic, and neo-vascular glaucoma, so that the initial use ofadjunctive medication may be the correctchoice.

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1999 83: 814-821Br J OphthalmolHolger Mietz, Birgit Raschka and Gnter K Krieglsteinperformed without antimetabolitesRisk factors for failures of trabeculectomies

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