Handbook of Clinical Trials in Ophthalmology Vinod Kumar, Neha Goel, Pooja Shah, AK Gupta
INDEX
ABCDEFGHIJKLMNOPRSTUVXZ
Page numbers followed by t refer to table.
A
Acetonide 111
ACG See Angle closure glaucoma
Acute spinal cord injury, treatment of 385
Acyclovir 3
prevention trial 3
Advanced glaucoma 37
intervention study 36
Aflibercept 118, 174, 175
group 174, 176
Age-related choroidal neovascularization 233
Age-related eye disease study 273, 276, 282
Age-related macular degeneration 109, 171, 186, 188, 194, 195, 202, 237, 249, 253, 257, 258, 273, 275
clinical trials in 186, 207, 245t, 253, 273, 281t
prevention trial, complication of 278, 282
subfoveal neovascular 220
treatment of 191
trials 230
Ahmed glaucoma valve 49
Albuminuria 81
Allergen 132
Allograft reaction episodes 12
Amblyopia 328, 337
clinical trials in 328
treatment 359
index 330
study 328, 331–335, 338, 340, 342–344, 346, 347, 349, 350, 352–355, 357–360, 363t
vision therapy for 349
Amblyopic eye 363t
Amikacin 296
Andhra Pradesh Eye Disease Study 59
Angioid streaks 188
Angle closure glaucoma 60, 64, 65t, 74
diagnosis of 58
Antiangiogenic drugs 133, 135
Antiglaucoma medications 14, 45
Antihypertensive drug therapy, moderate 85
Anti-retroviral therapy, active 402, 412
Anti-vascular endothelial growth factor 109, 210, 309
therapy 109, 120
treatment 147
Applanation tonometry 62
Aravind Comprehensive Eye Survey 61
Argon laser
trabeculoplasty 27
treatment 39
Argon study 186, 188
Aspergillus species 6
Aspirin 97
Atenolol 83
Atropine 331, 339, 347
eye drops 346
protocol 329
Autorefraction 127
Avastin 227, 228, 310
B
Bacterial endophthalmitis 295
management of 295
postoperative 295
Bacterial keratitis 8
Baseline vision 119
BCVA See Best corrected visual acuity
Benzoporphyrin 190
Best-corrected visual acuity 31, 53, 101, 110, 127, 132, 141, 151, 183, 201, 202, 219, 224, 255, 271, 389
score 194
Beta blocker betaxolol 27
Beta radiation epiretinal therapy 264
Bevacizumab 109, 118, 140, 146, 147, 174, 175, 227, 228, 230, 231, 237, 309
group 139
treatment 175
use of 140
Bilateral refractive amblyopia 343
treatment of 344
Biopsy 296
Blepharitis 4
Blood
glucose 86
control 83
group B 199
pressure 86
control 85, 88, 89
duration of 79
samples 12
tests 374
Brain, magnetic resonance imaging of 376
Branch retinal vein 165, 177
occlusion 153, 183
Branch vein occlusion study 153
Brolucizumab 148, 243
BRVO See Branch retinal vein occlusion
C
Canaloplasty
groups 44
results of 43
Captopril 83
Cardiovascular disease, risk of 97
Cataract 145, 198, 276, 405
extraction 42, 43, 84
formation 146
grading 59
progression 170
surgery 67, 105, 114, 115, 145, 325
Ceftazidime 296
Center for Disease Control and Prevention 403
Central corneal
measurement 31
scarring 10
thickness 53, 166
Central foveal thickness 127, 151, 183, 220
Central keratometry 16
Central macula 122
Central macular thickness 127, 140, 146, 256
Central nervous system 372
Central retinal
thickness 137, 151, 217, 219, 239
vein occlusion 54, 156, 167, 171, 173, 178, 183
Central subfield macular thickness 166
Central vein occlusion study 156
Central-involved diabetic macular edema 121
treatment for 120
Cerebrovascular accident 135, 136
CFT See Central foveal thickness
Chennai Glaucoma Study 63
Choriocapillaris 190
Choroidal melanoma 396, 398
Choroidal neovascularization 25, 202, 203t, 207, 210, 249, 253, 257, 258, 264, 279, 282
Chronic inflammation, cycle of 15
Clear lens extraction 45, 47
Clinically isolated syndrome 375
Clinically significant macular edema 88, 95, 101, 151
CMT See Central macular thickness
Collaborative initial glaucoma treatment study 29
Collaborative ocular melanoma study 396, 400t
Color vision 93
Confirmed microbiologic growth 297
Conjunctival hemorrhage 141, 172, 217
Conjunctival sac 52
Conjunctivitis 4
Contact lenses 16, 324
Contralateral eye involvement 406
Contrast sensitivity testing 303
Cornea 40
clinical trials in 1, 20t
donor study 13
Corneal allograft 12
Corneal astigmatism 16
Corneal endothelial cell density 13
Corneal scarring 10
Corneal tissue 1
Corneal transplantation 12
studies, collaborative 11
Corneal ulcers trial, steroid in 8
Corticosteroid 120, 131
treatment 2
Cotton-wool spots 91
Creatinine clearance 86
CRT See Central retinal thickness
CRVO See Central retinal vein occlusion
Cryotherapy 301, 303, 304
multicenter trial of 301
CSME See Clinically significant macular edema
Cycloplegic refraction 16
Cytomegalovirus 402, 403, 405–407, 409, 410, 412
D
De novo glaucoma procedure 51
Deferred panretinal photocoagulation 116
Dense macular hemorrhage 162
Denver developmental screening test 306
Dexamethasone 132, 144, 145, 146–148, 168, 175, 177–179
dose of 169
group 178
implant 147
intravitreal implant 168
single-dose 177
Diabetes
complications of 80
type 2 85
control 88, 113
and complications trial 80
duration of 79
effect of 113
epidemiology of 88
interventions and complications, epidemiology of 82
macula in 132
related deaths 85
treatment of 80
Diabetes mellitus 134, 151
insulin-dependent 88
non-insulin-dependent 85
type 1 141, 142
type 2 79, 83, 96, 141, 142
Diabetic macular edema 101, 103, 127, 136, 137, 143, 144, 146, 147, 151
development of 107
focal photocoagulation for 111
management of 139, 198
mild 106
pharmacotherapy in 149t
study, center-involved 114
treatment for 108–110, 115, 134
vision-impairing 118
Diabetic retinopathy 78–80, 83, 86, 87t, 101, 103, 115, 127, 131, 153, 188
clinical research network 103
clinical trials in 78, 90, 103, 131
landmark trials in 101t
regression of 91
risk of 121
study 90, 101
vitrectomy study 98, 101
Diabetic vascular complications 85
Disc stereophotographs 39
Disease-modifying therapies 376
Diurnal intraocular pressure 69
DME See Diabetic macular edema
Docosahexaenoic acid 282
Donor cornea, characteristics of 14
Dorzolamide 34
DR See Diabetic retinopathy
DRS See Diabetic retinopathy study
DRVS See Diabetic retinopathy vitrectomy study
Dry eye 15
disease 15
symptoms 15
E
Early lens extraction 45, 47
Early manifest glaucoma trial 27, 73
Early proliferative retinopathy 96
Early treatment diabetic retinopathy 101
study 46, 93, 133, 159, 291, 300
chart 256, 263
vision test 328
Edema, ranibizumab for 132
Eicosapentaenoic acid 22, 276
EMGT See Early manifest glaucoma trial
Emotional stress 4
Endophthalmitis 106, 117, 122, 138, 254
vitrectomy study 295, 299, 300t
Endothelial damage 190
Endothelial function 16
Endothelial tight junction proteins 168
Epimacular brachytherapy 264
Epiretinal membrane 18, 405
Epithelial keratitis 4
ETDRS See Early treatment diabetic retinopathy study
European Glaucoma Prevention Study 32, 33
Expanded disability status scale 379, 382, 383
Extracapsular cataract extraction 299
Eye 30, 94, 99, 100, 120, 170, 188
affected 6
course of 35
indicated for 97
involvement, second 406
natural history for 160
nepafenac in 115
number of 117
pain 141, 172
photocoagulation for 92
progression of 108
refractory 147, 148
treatment-naive 176
untreated 188
F
Fasting plasma glucose 84
Fibrocellular tissue 200
Fibrovascular proliferations 99
Fibrovascular tissue 200
Filtering surgery 35
Financial stress 4
First trabeculectomy fail 36
Fleischer's ring 10
Fluocinolone acetonide 143
sustained-release 131
Fluorescein angiography 138, 159, 187, 188, 211, 225, 235
Fluorouracil filtering surgery study 40
Focal laser photocoagulation 190
Focal photocoagulation 106
Foscarnet-ganciclovir cytomegalovirus retinitis trial 409
Fovea 154, 158
avascular zone 186
Foveal study 186, 188
Fuchs’ dystrophy 13
Fundus fluorescein
angiograms 155
angiography 132, 159
Fundus photographs 103
Fungal corneal ulcers 5
Fusarium species 6
G
Ganciclovir 410
Glasgow coma scale score 388
Glasses 16
Glaucoma 14, 27, 42, 58, 62, 63, 169
clinical trials in 27
detection of 62
epidemiological studies of 57, 74t
filtering surgery 40
landmark trials in 72t
laser in 66
laser trial 39
follow-up study 38
medication 49, 51
number of 68
neovascular 54, 92, 99
prevalence of 57, 62, 63
research foundation 73
secondary 62
surgery 14, 46, 144
risk of future 66
uncontrolled 176
Glaucomatous optic nerve 62
Glial dysfunction 147
Glycated hemoglobin 79
Glycemic control 82
duration of 79
Goldmann perimetry 95, 303
Gonioscopy 62
Good vision, chances of 100
Good visual acuity 196
Graft rejection, risk of 14
Gram stain 297
Gram-negative organisms 298
H
Head injury trial 387
Health and vision, perception of 198
Hematology testing 132
Hemiretinal vein occlusion 162
Hemorrhage 200
preretinal 164
retinal 159, 164
suprachoroidal 42
Hereditary optic disease outpatient study, rescue of 390, 391
Herpes simplex virus
epithelial keratitis trial 3
eye disease 4
Herpes simplex virus
infection 3
iridocyclitis 2
management of 1
Herpes stromal keratitis 1, 2
Herpetic eye disease 1, 3
management of 3
Horizon study 67
Hyperglycemia 84
severe 81
I
Idiopathic neovascular membranes 202
Immune recovery uveitis 403
Implantable dexamethasone 168
Indocyanine green angiography 260
Infant aphakia treatment study 324, 325, 327t
Infectious endophthalmitis 163
Infectious keratitis 5
Inflammatory cells 168
Influence glaucoma 27
Insulin 83, 84
injections 81
therapy 83
Intensive blood glucose control 84
International Optic Nerve Trauma Study 387
International Retina Group 147
Interquartile range 140
Intraocular injections 134, 166, 168
Intraocular lens 295, 324, 327
implantation 47
Intraocular pressure 42, 45, 51, 64, 65, 73, 92, 104, 131, 158, 183
elevation of 67
Intraocular ranibizumab 217
Intraocular steroids 135
Intraocular surgery 176
Intraoperative optical coherence tomography 17
Intraretinal edema 256
Intravitreal administration 171
Intravitreal aflibercept 118, 267, 271
injection, safety of 175
Intravitreal bevacizumab 108, 131, 139, 146, 234, 312
monotherapy 312
Intravitreal corticosteroid injection 163
Intravitreal dexamethasone 146
Intravitreal injections 122, 131, 145, 162, 171, 309
safety of 167
Intravitreal lucentis, safety assessment of 221
Intravitreal ranibizumab 110, 111, 113, 116, 117, 127, 271
Intravitreal steroids 109
Intravitreal triamcinolone 144, 164
acetonide 127
Intravitreous bevacizumab 140
IOP See Intraocular pressure
Iridocyclitis 4
Iris neovascularization 183
Iritis 4
Ischemic central retinal vein occlusion, treatment of 54
Ischemic heart disease 79
Ischemic optic neuropathy decompression trial 388
IVR See Intravitreal ranibizumab
IVTA See Intravitreal triamcinolone acetonide
J
Jupiter study 69
K
Kaplan-Meier analysis 209
Keratitis 4
Keratoconus
corneal scarring in 10
evaluation of 9
mild-to-moderate 10
Keratometry 326
Keratopathy 12
Kidney diseases 80
Krypton study 186, 188, 189
L
Landolt C chart 266
Laser 137
monotherapy 137
peripheral iridotomy 45
photocoagulation 127, 137, 154, 175, 186, 190, 202t
role of 93
therapy 139, 309
trabeculoplasty failure 38
treatment 39, 190
Laser-ranibizumab-triamcinolone study 109
Latanoprost 71
monotherapy 71
Later perfluoropropane 284
Leber's hereditary optic neuropathy 390
Lens 40, 324
Lesion
neovascular 188
subgroup analyses of 196
type of 186
Less severe retinopathy 96
Leukocyte
movement 168
recruitment 147
Lipid concentrations 86
Longitudinal optic neuritis study 373
Lower-extremity amputation 79
LP See Laser photocoagulation
Lucentis 134, 210
Lumbar puncture 374
Lymphocytotoxic antibodies 12
M
Macula 96
Macular edema 92, 95, 107, 118, 132, 134, 136, 153, 157, 161, 163, 165, 168, 179, 183, 255, 405
development of 116
duration of 169
photocoagulation on 96
treatment for 161, 165, 171
Macular grid laser photocoagulation 160
Macular laser 135
photocoagulation 141
procedures 136
Macular photocoagulation study 186
Macular program 58
Manifest refraction 10
Manual refraction 112
Mean binocular visual acuity 344
Menstrual periods 4
Mercury trial 71
Metamorphopsia score 291
Metformin 83, 84
Methylprednisolone 385, 386
Mild macular grid 127
Mitomycin C 42
MMG See Mild macular grid
Monoclonal antibody fragment 131
Monocular visual impairment 328
Monofocal episode 375
Multicenter cohort study 224
Multifocal episode 375
Multiple sclerosis 372, 374, 375, 381, 394
study, early treatment of 380
trial outcomes index, functional assessment of 383
Mycotic infections 7
Mycotic ulcer treatment trial 5, 7
Myocardial infarction 135
Myopia 63
high 188
pathologic 193, 194
Myopic choroidal neovascularization 194
N
Naloxone 385, 386
National Acute Spinal Cord Injury Study 385
National Eye Institute 5, 73, 90, 328
National Health Service 233
National Institute of Diabetes 80
National Institutes of Health 301
Neovascular age-related macular degeneration 207, 223, 225, 227, 243
treatment of 225, 242
Neovascular complications, treatment of 162
Neovascular proliferation, active 100
Neovascularization, development of 153, 154, 156
Nephropathy 80
Netarsudil 71
drop of 71
Neuronal cell death 147
Neuro-ophthalmology, clinical trials in 372, 393t
Neuropathy 80, 86
Neurosensory retina 190
Nocardia ulcers 9
Nonarteritic anterior ischemic optic neuropathy 388
Non-contact specular microscopy 326
Noncytomegalovirus ocular opportunistic infections 40
Nonfatal myocardial infarctions 136
Non-fusarium group 7
Noninfectious endophthalmitis 163
Non-nocardia ulcer 9
Nonocular safety 168
Nonproliferative diabetic retinopathy 90, 95, 127
Nonproliferative retinopathy, mild to moderate 81
Nonrandomized small tumor pilot study 398
Non-staphylococcus epidermidis 298
Normal tension glaucoma study, collaborative 34
NPDR See Nonproliferative diabetic retinopathy
O
OAG See Open-angle glaucoma
Occlusion therapy 328, 331
Ocular herpes simplex infection 4
Ocular histoplasmosis syndrome 198
Ocular hyperemia 141
Ocular hypertension 32, 69, 70, 73, 74, 169
study 66
treatment of 30, 52
Ocular hypotensive medication 32
Ocular inflammation 176
Ocular motility 326
Ocular neovascularization 208
Ocular treatment index 325
OHT See Ocular hypertension
Omega-3 long-chain polyunsaturated fatty acids 276
Open-angle glaucoma 27, 43, 52, 59, 63, 65, 70, 73, 74
results of 64t
Open-label randomized controlled trial 319
Ophthalmic diseases, management of 17
Ophthalmology, clinical trials aids in 412t
Ophthalmoscopy, indirect 99
Optic disc 31, 32
Optic nerve
evidence of 39
typical 44
Optic neuritis 372
treatment 373
trial 372
Optical biometry 326
Optical coherence tomography 17, 105, 211, 217, 227, 255
Oral acyclovir, efficacy of 1
Oral voriconazole 7
Ozurdex 132
P
PACG See Primary angle closure glaucoma
Panretinal photocoagulation 90, 106, 116, 127, 135, 183
treatment to 111
Parenting stress index 325
Pars plana vitrectomy 284, 290, 293, 296, 300
Patching protocol 329
PDR See Proliferative diabetic retinopathy
Pediatric eye disease 363t
investigator group 328, 349
Pegaptanib 209
sodium 208
Penetrating keratoplasty 3
Peribulbar triamcinolone acetonide 106
Peripheral diabetic retinopathy lesions 121
Peripheral retinal
ablation 309
vessels, development of 312
Peripheral vision, loss of 116
Phakic eyes 43
Pharmacotherapy 116
Photodynamic therapy 191, 202, 203t, 210, 253, 266, 271
application of 190
Photokeratoscopy 16
Pigmentary glaucoma 29, 44
Placebo 386
controlled clinical trial 376
Placental growth factor 171
Pneumatic retinopexy 290, 292
POAG See Primary open-angle glaucoma
Point-of-care glycated hemoglobin 113
Polymorphous dystrophy, posterior 13
Polypoidal choroidal vasculopathy 257, 261, 267, 271
treatment of 266
Port delivery system 225
Prednisolone phosphate 1
Presumed ocular histoplasmosis 186, 202
Primary angle closure glaucoma 46, 58, 65, 66, 74
treatment of 45, 47
Primary open-angle glaucoma 64, 74
Primary rhegmatogenous retinal detachment 290
management of 290
Proliferative diabetic retinopathy 79, 90, 116, 127, 133
development of high-risk 96
severe 99
Proliferative retinopathy 90
Proteinuria, gross 79
PRP See Panretinal photocoagulation
Pseudoexfoliation 44
glaucoma 29
Pseudophakia 405
Pseudophakic corneal edema 13
Pseudophakic eyes 147
Pulse oximetry 314
R
Radial keratotomy 16
prospective evaluation of 16
Radiation therapy 264
Randomized clinical trial 261, 342, 348, 376
Randot preschool stereoacuity test 336
Ranibizumab 109, 110, 117, 118, 131, 134, 136, 165, 166, 177–179, 210, 212, 216, 225, 230, 253, 254, 260, 266, 271, 319, 320
efficacy and safety of 216, 261
efficacy of 136
extension trial of 223
injection 111, 134
monotherapy 137, 138, 258, 260
safety of 177, 178
study of 219
treatment 177
Refraction 57
Rehabilitative services 78
Renal disease, severe 99
Residual subretinal fluid 19
Restore lost vision 135
Retina 40
Retinal capillary perfusion 161
Retinal detachment 99, 106, 163, 198, 406
clinical trials in 284, 293t
management of 284
rates of 299
Retinal disorders 103
Retinal glial cell 147
Retinal hemorrhages, extensive 91
Retinal ophthalmology 113
Retinal photographs 84
Retinal pigment epithelium 190
Retinal thickening 106, 107, 114, 148
measurement of 114
Retinal vascular
disease 158
occlusions, clinical trials in 153, 180t
Retinal vein occlusion 153, 168, 175, 179
comparative treatments for 174
corticosteroid for 161
Retinitis 402, 403, 405–407, 409, 410
previously diagnosed 403
progression 403, 406
Retinopathy 176
progression of 92
severe 96
stage of 92
Retinopathy of prematurity 301, 312, 319
clinical trials in 301, 321t
cryotherapyfor 301
effects of light reduction on 315
Retinopathy of prematurity study
early treatment for 304
high oxygen percentage in 314
photographic screening for 316
Retinotomy 286
Rhegmatogenous retinal detachment 200, 201, 287, 293
Rhopressa 70
Rocket trial 70
S
Scanning laser ophthalmoscopy 32
Scleral buckling 287
Scleral flap 42
Selective laser trabeculoplasty 51
Severe vision loss, development of 91
Sham treatment 191
Silicone oil
removal 286
study 284
Silicone study 286
classification system 286
long-term outcome in 286
Slit-lamp
biomicroscopy 62
photograph 159
Smoking, history of 14
Snellen equivalent 138
Spectral-domain ocular coherence tomography 225
Staphylococcus
aureus 297, 298
epidermidis 298
haemolyticus 298
lugdunensis 298
Stereoscopic fundus evaluation 59
Steroid
inflammatory action of 8
related toxicities 163
treatment 2
Stromal keratitis, development of 4
Subclinical diabetic macular edema study 108
Subfoveal lesions 188
Subfoveal recurrent 189
Submacular surgery 198, 201
trials 198, 199, 204t
Subretinal fluid 254
Subretinal pigment epithelial fluid 256
Subtenon's injections 106
Sulfonylurea 83, 84
Sulfur hexafluoride 284
Sun exposure 4
Supplemental therapeutic oxygen 312
Systemic antibiotics 297
role of 295
Systemic bevacizumab therapy 227
T
Teller acuity card procedure 306
Therapeutic keratoplasty 6, 7
Titmustest 336
Tonometry 326
Topical antibiotics 122
Topical antiglaucoma agents 31
Topical corticosteroids 2
Topical natamycin 8
Topical prednisolone phosphate 8
Topical steroids, receiving 2
Topical therapy 45
Topical trifluridine 4
Torpedo trial 255
Total macular volume 122
Trabeculectomy 42, 43, 45, 145
group 43, 45
study 42
Transient photosensitivity reactions 192
Transient visual disturbances 197
Traumatic optic neuropathy 385
Triamcinolone 109, 110, 111
Trifluridine prophylaxis 2
U
Ultrasonic corneal thickness 16
Urinalysis 132
Urine albumin 84
V
VA See Visual acuity 183
Vancomycin 296
Vascular endothelial growth factor 131, 183, 207, 249, 253
inhibition study 208
trap-eye 238, 240
VEGF See Vascular endothelial growth factor
Vellore eye study 57
Verteporfin 190–193, 196, 210
photodynamic therapy 190, 193, 261, 271
efficacy and safety of 260
plus ranibizumab 257, 258
therapy 193, 196, 197
favor of 196
use of 193
treatment 193, 197
group 195
Vision loss
cause of 168
from macular edema, risk for 154
mild 119
moderate 105, 195
rate of 135
severe 195
Vision related subscales 138
Vision specific quality 11
Visual activities 29
Visual acuity 29, 37, 41, 51, 57, 62, 84, 91, 99, 100, 103, 120, 127, 133, 142, 147, 159, 162, 164, 165, 188–190, 192, 196, 199, 202, 208, 211, 215, 221, 234, 254, 291, 327, 330, 331, 333, 334, 339, 341, 346, 387
course of 99
improvement in 199, 350
loss 191, 407
risk of severe 201
masked assessment of 343
measurements 164
evaluation of 112
monitoring 171
reduced 172
risk of 100
spectacle-corrected 16
stabilization 193
Visual benefit 144
Visual field 31, 93, 97, 404
decrease of 38
defects 389
loss 27, 407
advanced 28
testing 303
Visual function 93
preservation of 42
Visual impairment 138, 405
Visual improvement 119, 143, 170
Visual loss 35, 79, 92
Visual prognosis 298
Vitrectomy 97, 290, 295, 297
early 98, 99
evaluation of 105
primary 287
Vitreomacular traction 105, 127
Vitreous hemorrhage 18, 99, 100, 113, 127, 158, 163, 164
development of 154, 155
experience 156
severe 98, 99
Vitreous tap 296
Vogt's striae 10
Voriconazole 5, 6
Voyager study 52
X
Xenon technique 91
Z
Zidovudine 410
×
Chapter Notes

Save Clear