Ab interno trabecular bypass surgery with iStent for open angle glaucoma
Appendices
Appendix 1. CENTRAL search strategy
#1 MeSH descriptor: [Glaucoma, Open‐Angle] explode all trees
#2 MeSH descriptor: [Intraocular Pressure] explode all trees
#3 MeSH descriptor: [Ocular Hypertension] explode all trees
#4 OAG or POAG or IOP or OHT
#5 simple near/3 glaucoma*
#6 open near/2 angle near/2 glaucoma*
#7 chronic near/2 glaucoma*
#8 secondary near/2 glaucoma*
#9 low near/2 tension near/2 glaucoma*
#10 low near/2 pressure near/2 glaucoma*
#11 normal near/2 tension near/2 glaucoma*
#12 normal near/2 pressure near/2 glaucoma*
#13 pigment near/2 glaucoma*
#14MeSH descriptor: [Exfoliation Syndrome] this term only
#15 exfoliat* near/2 syndrome*
#16 exfoliat* near/2 glaucoma*
#17 pseudoexfoliat* near/2 syndrome*
#18 pseudoexfoliat* near/2 glaucoma*
#19 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18
#20 MeSH descriptor: [Stents] explode all trees
#21 iStent
#22 #20 or #21
#23 #19 and #22
Appendix 2. MEDLINE Ovid search strategy
1. randomized controlled trial.pt.
2. (randomized or randomised).ab,ti.
3. placebo.ab,ti.
4. dt.fs.
5. randomly.ab,ti.
6. trial.ab,ti.
7. groups.ab,ti.
8. or/1‐7
9. exp animals/
10. exp humans/
11. 9 not (9 and 10)
12. 8 not 11
13. exp glaucoma open angle/
14. exp intraocular pressure/
15. ocular hypertension/
16. (OAG or POAG or IOP or OHT).tw.
17. (simple$ adj3 glaucoma$).tw.
18. (open adj2 angle adj2 glaucoma$).tw.
19. (primary adj2 glaucoma$).tw.
20. (chronic adj2 glaucoma$).tw.
21. (secondary adj2 glaucoma$).tw.
22. (low adj2 tension adj2 glaucoma$).tw.
23. (low adj2 pressure adj2 glaucoma$).tw.
24. (normal adj2 tension adj2 glaucoma$).tw.
25. (normal adj2 pressure adj2 glaucoma$).tw.
26. (pigment$ adj2 glaucoma$).tw.
27. exfoliation syndrome/
28. (exfoliat$ adj2 syndrome$).tw.
29. (exfoliat$ adj2 glaucoma$).tw.
30. (pseudoexfoliat$ adj2 syndrome$).tw.
31. (pseudoexfoliat$ adj2 glaucoma$).tw.
32. or/13‐31
33. exp Stents/
34. istent.tw.
35. 33 or 34
36. 32 and 35
37. 12 and 36
The search filter for trials at the beginning of the MEDLINE strategy is from the published paper by Glanville 2006.
Appendix 3. Embase Ovid search strategy
1. exp randomized controlled trial/
2. exp randomizations/
3. exp double blind procedure/
4. exp single blind procedure/
5. random$.tw.
6. or/1‐5
7. (animal or animal experiment).sh.
8. human.sh.
9. 7 and 8
10. 7 not 9
11. 6 not 10
12. exp clinical trial/
13. (clin$ adj3 trial$).tw.
14. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw.
15. exp placebo/
16. placebo$.tw.
17. random$.tw.
18. exp experimental design/
19. exp crossover procedure/
20. exp control group/
21. exp latin square design/
22. or/12‐21
23. 22 not 10
24. 23 not 11
25. exp comparative study/
26. exp evaluation/
27. exp prospective study/
28. (control$ or prospectiv$ or volunteer$).tw.
29. or/25‐28
30. 29 not 10
31. 30 not (11 or 23)
32. 11 or 24 or 31
33. open angle glaucoma/
34. intraocular pressure/
35. intraocular hypertension/
36. (OAG or POAG or IOP or OHT).tw.
37. (open adj2 angle adj2 glaucoma$).tw.
38. (primary adj2 glaucoma$).tw.
39. (chronic adj2 glaucoma$).tw.
40. (secondary adj2 glaucoma$).tw.
41. (low adj2 tension adj2 glaucoma$).tw.
42. (low adj2 pressure adj2 glaucoma$).tw.
43. (normal adj2 tension adj2 glaucoma$).tw.
44. (normal adj2 pressure adj2 glaucoma$).tw.
45. (pigment$ adj2 glaucoma$).tw.
46. exfoliation syndrome/
47. (exfoliat$ adj2 syndrome$).tw.
48. (exfoliat$ adj2 glaucoma$).tw.
49. (pseudoexfoliat$ adj2 syndrome$).tw.
50. (pseudoexfoliat$ adj2 glaucoma$).tw.
51. or/33‐50
52. Stent/
53. istent.tw.
54. 52 or 53
55. 51 and 54
56. 32 and 55
Appendix 4. ISRCTN search strategy
iStent
Appendix 5. ClinicalTrials.gov search strategy
iStent
Appendix 6. WHO ICTRP search strategy
iStent
Appendix 7. FDA search strategy
istent AND random OR randomly OR randomised OR randomized
Appendix 8. Data on study characteristics
| Mandatory items | Optional items | |
| Methods | ||
| Study design | · Parallel group RCTi.e. people randomized to treatment · Within‐person RCTi.e. eyes randomized to treatment · Cluster RCTi.e. communities randomized to treatment · Cross‐over RCT · Other, specify | Number of study arms Method of randomization Exclusions after randomization Losses to follow up Number randomized/analyzed Method of masking How were missing data handled? e.g. available case analysis, imputation methods Reported power calculation (Y/N), if yes, sample size and power Unusual study design/issues |
| Eyes Unit of randomization/unit of analysis | · One eye included in study, specify how eye selected · Two eyes included in study, both eyes received same treatment, briefly specify how analyzed (best/worst/average/both and adjusted for within person correlation/both and not adjusted for within person correlation) and specify if mixture of one eye and two eyes · Two eyes included in study, eyes received different treatments,specify if correct pair‐matched analysis done | |
| Participants | ||
| Country | Setting Ethnic group Method of recruitment Participation rate Equivalence of baseline characteristics (Y/N) Diagnostic criteria | |
| Total number of participants | This information should be collected for total study population recruited into the study. If these data are reported for the people who were followed up only, please indicate. | |
| Number (%) of men and women | ||
| Average age and age range | ||
| Inclusion criteria | ||
| Exclusion criteria | ||
| Interventions | ||
| Intervention (n= ) Comparator (n= ) See MECIR 65 and 70 | · Number of people randomized to this group · Intervention name · Comparator name · Specify whether phacoemulsification, or other intervention, performed at same time as intervention | iStent or iStent inject surgical parameters, e.g. degrees of meshwork ablated, electrosurgical power Comparator parameters, e.g. dosage of drugs |
| Outcomes | ||
| Primary and secondary outcomes as defined in study reports See MECIR R70 | · Proportion of participants who are drop‐free at 2 years follow‐up · Mean change in number of IOP‐lowering drops taken per day from baseline to 2 years follow‐up · Mean change in IOP from baseline to 2 years follow‐up · Health‐related quality of life measures at 2 years follow‐up · Intraoperative complications Adverse events reported (Y/N) | Planned/actual length of follow‐up |
| Notes | ||
| Date conducted | Specify dates of recruitment of participants mm/yr to mm/yr | Full study name: (if applicable) Date of publication Reported subgroup analyses (Y/N) Were trial investigators contacted? |
| Sources of funding | ||
| Declaration of interest See MECIR 69 | ||
