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Study Title and Description

Lens extraction for uncontrolled angle-closure glaucoma: long-term follow-up.



Key Questions Addressed
1 What is the effect of lens extraction for chronic angle-closure glaucoma?
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Primary Publication Information
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TitleData
Title Lens extraction for uncontrolled angle-closure glaucoma: long-term follow-up.
Author Gunning FP., Greve EL.
Country -- Not Found --
Year 1998
Numbers Pubmed ID: 9795850

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Lens extraction for chronic angle-closure glaucoma 2009
Arms
Number Title Description Comments
1 Lens extraction Extracapsular cataract extraction with posterior chamber intraocular lens (PCIOL). Subconjunctival steroids and pilocarpine ointment were given after the surgical procedure.
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2 Trabeculectomy Trabeculectomy with postoperative 5-Fluorouracil administered in 6 eyes.
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Design Details
Question... Follow Up Answer Follow-up Answer
Type of study Retrospective cohort study
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Was the control group representative of the underlying population? Cannot tell from the publication.
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Losses to follow-up and reasons for loss to follow-up controls: 0. Cases: 1 eye, which needed filtration surgery was not analyzed.
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Country The Netherlands.
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Cases or Intervention 1 extracapsular cataract extraction with posterior chamber intraocular lens (PCIOL). Subconjunctival steroids and pilocarpine ointment were given after the surgical procedure.
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Control or Intervention 2 trabeculectomy with postoperative 5-Fluorouracil administered in 6 eyes.
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Primary outcome as defined in the study no explicit primary outcome stated a priori. Main results were focused on mean IOP.
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Study period 1987 to 1994.
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Age Mean (SD) was 66.5 (9.7) years in lens extraction group and 64.6 (11.9) years in trabeculectomy group.
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Gender 61% in lens extraction group and 79% in trabeculectomy group were females.
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Inclusion criteria no explicit inclusion criteria reported. Patients in lens extraction group were selected based on gonioscopic appearance as evaluated by a single author. Patients in the control group underwent trabeculectomy during the same period.
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Exclusion criteria no explicit exclusion criteria mentioned.
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Equivalence of baseline characteristics baseline age appears lower in controls but difference was not statistically significant. Similar in preoperative IOP values. One patient in lens extraction group had 20/200 visual acuity pre-operatively while 5 patients in trabeculectomy group had preoperative visual acuity of 20/200 or worse.
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Number of participants (eyes) in Intervention 1 group 18 (22)
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Number of participants (eyes) in Intervention 2 group 19 (25)
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Length of follow up Planned: not stated. Actual: lens extraction group, range 15 to 90 months; trabeculectomy group, range 11 to 83 months.
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Measurement of primary outcome in the study not clearly reported.
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Secondary outcomes as defined in the study best-corrected visual acuity; postoperative anti-glaucoma medication use; visual field and gonioscopic findings.
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Measurement of secondary outcomes in the study visual acuity was measured using Snellen charts, no information on measurement of visual field. Goldmann 3-mirror goniolens was used to evaluate the angle.
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Intervals at which outcome assessed no specific intervals reported.
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Reported information on cost of interventions none.
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Reported information on quality of life none.
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Were the criteria for allocation of participants to the treatment and control groups explicitly reported? ... No ... Criteria were not clearly defined. The authors do not explain how participants were allocated to treatment arms.
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Can the above criteria be explicitly related to the outcome? ... Yes ... Patient selection could have influenced the outcome if some with a presumed better prognosis were allocated into one arm over another.
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Was there evidence of a consecutive sample or a clearly defined patient population or some other method to minimize the chance that clinicians preferentially selected patients with favorable outcomes or that patients with better outcomes volunteered? No evidence. No information on how patients were selected to receive the two interventions.
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How were the controls selected? Not explained.
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Were appropriate statistical/ case-mix methods used to adjust for confounding factors? Sample size was small, and the authors report that age, preoperative IOP, and number of preoperative ocular hypotensive medicines were not statistically significantly different. Residual confounding may have existed. There was no adjustment in the analyses.
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Were the factors adjusted for in the analyses, specified a priori? No adjustments were made.
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Was the measurement of the confounding factors in the participants consistently adequate? No. The gonioscopic appearance at baseline should have been included. Also, there is no report on the consistency of gonioscopic measurements.
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Was consistency achieved in allocation, administration of treatments and recording of the treatments? Unclear.
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Was the treatment/intervention confirmed in an objective way and not determined exclusively by self reports? Yes. The intervention was a surgical procedure.
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Was outcome assessment conducted in a masked fashion (if the study was prospective)? Unclear.
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Were criteria/protocols for outcome assessment standardized and/or pre-specified? Were there deviations from the protocol? Unclear.
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Was the method of outcome assessment valid? Unclear.
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Was outcome assessed in the same way in both groups? No - IOP assessment in lens extraction group was preceded by an oral carbonic anhydrase inhibitor and it is not clear if the IOP in this group was also obtained from diurnal curves.
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Results & Comparisons


Results Data
Outcome: Proportion of participants with evidence of progression of visual field loss      Population: All Participants
Time Point Measure Lens extraction Trabeculectomy


11-90 months

N Analyzed 21 25
Counts 5 5
Outcome: Visual acuity      Population: All Participants
Time Point Measure Lens extraction Trabeculectomy


11-90 months

N Analyzed 21 25
Counts 1 12
Outcome: Gonioscopic findings in the participants      Population: All Participants
Time Point Measure Lens extraction Trabeculectomy


11-90 months

N Analyzed 21 25
Counts 3/7 eyes with 50% or more closed chamber angle before surgery improved to a "narrow angle" Not reported
Outcome: Mean change in IOP      Population: All Participants
Time Point Measure Lens extraction Trabeculectomy


11-90 months

N Analyzed 21 25
Mean 11.84 14.24
SD 7.25 9.86
Outcome: Number of medications to control IOP      Population: All Participants
Time Point Measure Lens extraction Trabeculectomy


11-90 months

N Analyzed 21 25
Mean 1.3 0.52
SD 0.8 0.8

Adverse Events
Arm or Total Title Description Proportion of adverse events Comments
Lens extraction Early IOP elevation 10/22
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Trabeculectomy 0/25
Total
Lens extraction Persistent IOP elevation leading to trabeculectomy 1/22
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Trabeculectomy 0/25
Total
Lens extraction Pre-pupillary fibrin and posterior synechiae 5/22
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Trabeculectomy 0/25
Total
Lens extraction Wound dehiscence 1/22
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Trabeculectomy 0/25
Total
Lens extraction Central retinal vein occlusion 1/22
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Trabeculectomy 0/25
Total
Lens extraction Choroidal detachment 0/22
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Trabeculectomy 9/25
Total
Lens extraction Flat anterior chamber 0/22
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Trabeculectomy 2/25
Total
Lens extraction Peripheral iris-cornea touch 0/22
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Trabeculectomy 10/25
Total
Lens extraction Transient hypotony 0/22
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Trabeculectomy 2/25
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Lens extraction Hyphema 0/22
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Trabeculectomy 1/25
Total