Evidence Table 21Non-penetrating surgery plus augmentation vs. non-penetrating surgery

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Neudorfer et al., 2004111

Study design:
RCT

Evidence level:
1+

Duration of follow-up:
At least 24 months. Clinical visits that extended longer than 27 months were considered as 2 year postoperative follow ups.
Patient group: POAG

Setting: single centre - Israel

Inclusion criteria:
Open angle glaucoma patients: Exclusion criteria:
  • Secondary glaucoma, neovascular or juvenile glaucomas
  • iridocorneal endothelial syndrome
  • uveitis
All patients
N: 26 (26 eyes)
Age (mean ± SD): NR
M/F: 13/13
Mean IOP:
Drop outs: 0

Group 1
N: 13
Age (mean ± SD): 65.8 ± 6.8
M/F: 5/8
Mean IOP: 26.5 ± 2.5
Drop outs: 0

Group 2
N: 13
Age (mean ± SD): 68.1 ± 8
M/F: 8/5
Mean IOP: 31.5 ± 5.7
Drop outs: 0
Group 1
Deep Sclerectomy with collagen implant only

Group 2
Deep Sclerectomy with collagen implant + MMC 0.3mg/ml for 3 minutes

Examination methods:
IOP. Best corrected visual acuity for distance based on the results of retinoscopy and manifest refraction.
Mean preoperative IOPGroup 1: 26.5 ± 2.5
Group 2: 31.5 ± 5.7
p value: significant
Funding: NR

Limitations: Additional outcomes:

Visual acuity deterioration (>2 lines on the Snellen chart)
Group 1: 0/13
Group 2: 0/13

Visual acuity deterioration (1 line on the Snellen chart due to cataract formation)
Group 1: 1/13
Group 2: 2/13

Notes:
Mean IOP at 12 monthsGroup 1: 17.2 ± 3.9
Group 2: 15.6 ± 3.5
p value: significant baseline-12 months for each group not between groups
IOP % difference from baseline to 12 monthsGroup 1: 34.8 ± 15.3
Group 2: 47.8 ±18.1
p value: not significant between groups
Mean IOP at 24 monthsGroup 1: 17.8 ± 2.8
Group 2: 15.8 ± 5.6
p value: significant baseline-24 months for each group not between groups
IOP % difference from baseline to 24 monthsGroup 1: 32.1 ± 12.2
Group 2: 48.1 ± 17.2
p value: p = 0.01 significant
IOP success <21 mmHg without medicationsGroup 1: 5/13
Group 2: 4/13
p value: not significant
Number of patients with unacceptable IOP ≥ 21 mmHg (with or without meds) at 12 monthsGroup 1: 2/13
Group 2: 0/13
Number of patients with unacceptable IOP ≥ 21 mmHg (with or without meds) at 24 monthsGroup 1: 1/13
Group 2: 1/13
Mean number of medications at baselineGroup 1: 2.9 ± 0.6
Group 2: 3.7 ± 0.6
p value: p < 0.05 significant
Mean number of medications at 12 monthsGroup 1: 1.3 ± 1.2
Group 2: 1.8 ± 1.5
p value: significant baseline-12 months for each group not between groups
Mean number of medications at 24 monthsGroup 1: 1.8 ± 0.9
Group 2: 2.0 ± 1.5
p value: significant baseline- 24 months for each group not between groups
Complications at 24 monthsPostoperative Hyphaema
Group 1: 1/13
Group 2: 2/13
Filtering blebs
Group 1: 2/13
Group 2: 3/13

Neither bleb leak nor hypotony were present in any of the patient groups.

Abbreviations: NR=not reported, NA=not applicable, M/F=male/female, N=total number of patients randomised, SD=Standard Deviation, SE(M)=Standard Error (of the mean), ITT – Intention to Treat etc

From: Appendix D, Evidence tables

Cover of Glaucoma
Glaucoma: Diagnosis and Management of Chronic Open Angle Glaucoma and Ocular Hypertension.
NICE Clinical Guidelines, No. 85.
National Collaborating Centre for Acute Care (UK).
Copyright © 2009, National Collaborating Centre for Acute Care.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

The rights of National Collaborating Centre for Acute Care to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.