To present visual acuity (VA) and related findings from patients enrolled in o ne of the Submacular Surgery Trials (SST) evaluating surgical removal versus obs ervation of subfoveal choroidal neovascularization second...To present visual acuity (VA) and related findings from patients enrolled in o ne of the Submacular Surgery Trials (SST) evaluating surgical removal versus obs ervation of subfoveal choroidal neovascularization secondary to age related mac ular degeneration (SST Group N Trial). Randomized clinical trial. Eligible patie nts had age related macular degeneration with subfoveal choroidal neovasculariz ation, some with a classic pattern on fluorescein angiography, and best correct ed VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no tre atment in the macula. Any contiguous blood had to account for < 50%of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2 ]) . Randomization was stratified by VA and by clinical center. All patients were s cheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes. A successful outcome was defined a priori to be ei ther improvement of BCVA or VA no more than 1 line (7 letters) worse than baseli ne at the 24 month examination. Of 454 patients enrolled, 228 study eyes were a ssigned to observation and 226 to surgery. The percentages of eyes that had succ essful outcomes were similar in the 2 arms: 44%assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24 month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initiall y phakic eyes had cataract surgery by the 24 month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occ urred in 12 surgery eyes (5%) and 1 observation eye. Submacular surgery, as per formed in this clinical trial, did not improve or preserve VA for 24 months in m ore eyes than observation and is not recommended for patients with similar lesio ns.展开更多
To present best corrected visual acuity (BCVA) findings and other clinical ou tcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (S ST) evaluating surgical removal versus observation of pred...To present best corrected visual acuity (BCVA) findings and other clinical ou tcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (S ST) evaluating surgical removal versus observation of predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) associated with age related macular degeneration. Randomized clinical trial (SST Group B Trial). Eli gible patients had subfoveal choroidal neovascular lesions greater than 3.5 disk areas (8.9 mm2)composed of at least 50%blood (either blood or CNV underlying t he center of the foveal avascular zone) and BCVA of 20/100 to light perception i n the study eye. Patients were assigned randomly at time of enrollment to observ ation or surgical removal of blood and any associated CNV. A successful outcome was defined a priori as either improvement in visual acuity (VA), no change in V A, or a decline in VA of no more than 1 line (7 letters) from baseline to the 24 month examination based on an intent to treat analysis. Of 336 patients enro lled, 168 were assigned to each treatment arm; treatment arms were balanced by b aseline characteristics. Of 1501 expected examinations 3 months through 36 month s after baseline, 1370 (91%) were performed. Loss of ≥2 lines (≥8 letters) of VA occurred in 56%of surgery eyes, versus 59%of observation eyes examined at 24 months. Although severe loss of VA was not the primary outcome of interest, s urgery more often prevented such loss: 36%in the observation arm versus 21%in the surgery arm at the 24 month examination (χ2 P=0.004). Of initially phakic eyes, the cumulative percentage that had undergone cataract surgery by 24 months was 44%in the surgery arm, compared with 6%in the observation arm. Twenty se ven eyes (16%) in the surgical arm, compared with 3 eyes (2%) in the observati on arm, had a rhegmatogenous retinal detachment (RD). Submacular surgery as perf ormed in the SST Group B Trial did not increase the chance of stable or improved VA (the primary outcome of interest) and was associated with a high risk of rhe gmatogenous RD, but did reduce the risk of severe VA loss in comparison with obs ervation.展开更多
To describe health related quality of life (HRQOL), overall and in patients w ith unilateral or bilateral choroidal neovascularization (CNV), in a clinical tr ial (Group N Trial) comparing observation and surgical rem...To describe health related quality of life (HRQOL), overall and in patients w ith unilateral or bilateral choroidal neovascularization (CNV), in a clinical tr ial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age related macular degeneration (AMD). Randomized clinical trial. Eligible patients had untreated subfoveal CNV and AMD, best corrected visual a cuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a to tal subfoveal lesion size of ≤9.0 disc areas in the study eye. Health related quality of life data (the National Eye Institute Visual Function Questionnaire [ NEI VFQ], 36 item Short Form Health Survey [SF-36], and Hospital Anxiety a nd Depression Scale [HADS] ) and clinical data were collected at baseline and at 6 , 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence. Two yea r change in the NEI VFQ. Of 454 patients enrolled, 228 were assigned to observa tion and 226 to surgery. At baseline, median overall NEI VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation g roup had lost a median of 3 points (95%confidence interval [CI]:-6 to-2), a nd the surgery group gained a median of 1 point (CI:-1 to 3). The largest differe nce was observed for the mental health subscale, where the observation group los t a median of 5 points (CI:-5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2 year changes in NEI VFQ scores favored surgery by up to 10 points for unilateral cases and u p to 8 points for bilateral cases. No treatment difference in 2 year change was observed for the SF-36 physical component summary; 2 year change in the menta l component summary favored surgery by 2 points. Few patients (2%-4%) had HAD S definite anxiety or depression at baseline or at 24 months. Although HRQOL out comes were better in the submacular surgery arm than in the observation arm, sur gery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms.展开更多
Purpose: To investigate the effects of photodynamic therapy (PDT) on juxtafove al choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a clinical patient material. Methods: Thirty eyes in 30...Purpose: To investigate the effects of photodynamic therapy (PDT) on juxtafove al choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a clinical patient material. Methods: Thirty eyes in 30 consecutive patients with AMD and a juxtafoveal CNV underwent PDT with verteporfin with standard par ameters. The patients were followed up for 12 months and retreated every 12 week s in the event of leakage from CNV. Nineteen patients (63.3%) had a predominant ly classic CNV, eight (26.7%) had a 100%occult CNV and three (10%) had a mini mally classic lesion. In 27 patients (90%) the lesion was ≤3 MPS (Macular Phot ocoagulation Study) disc diameters and ≤3 MPS disc areas. Results: There was a positive correlation between duration of symptoms and loss of visual acuity at 1 2 months (P < 0.02). For predominantly classic lesions, there was a positive cor relation between duration of symptoms and lesion size(P < 0.005). At 12 months, leakage had stopped after 3.3±0.9 treatments in 80%of the patients. Visual acu ity remained stable in 63.3%of the patients. Conclusion: Photodynamic therapy a ppears to be beneficial in patients with AMD and juxtafoveal CNV.展开更多
文摘To present visual acuity (VA) and related findings from patients enrolled in o ne of the Submacular Surgery Trials (SST) evaluating surgical removal versus obs ervation of subfoveal choroidal neovascularization secondary to age related mac ular degeneration (SST Group N Trial). Randomized clinical trial. Eligible patie nts had age related macular degeneration with subfoveal choroidal neovasculariz ation, some with a classic pattern on fluorescein angiography, and best correct ed VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no tre atment in the macula. Any contiguous blood had to account for < 50%of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2 ]) . Randomization was stratified by VA and by clinical center. All patients were s cheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes. A successful outcome was defined a priori to be ei ther improvement of BCVA or VA no more than 1 line (7 letters) worse than baseli ne at the 24 month examination. Of 454 patients enrolled, 228 study eyes were a ssigned to observation and 226 to surgery. The percentages of eyes that had succ essful outcomes were similar in the 2 arms: 44%assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24 month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initiall y phakic eyes had cataract surgery by the 24 month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occ urred in 12 surgery eyes (5%) and 1 observation eye. Submacular surgery, as per formed in this clinical trial, did not improve or preserve VA for 24 months in m ore eyes than observation and is not recommended for patients with similar lesio ns.
文摘To present best corrected visual acuity (BCVA) findings and other clinical ou tcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (S ST) evaluating surgical removal versus observation of predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) associated with age related macular degeneration. Randomized clinical trial (SST Group B Trial). Eli gible patients had subfoveal choroidal neovascular lesions greater than 3.5 disk areas (8.9 mm2)composed of at least 50%blood (either blood or CNV underlying t he center of the foveal avascular zone) and BCVA of 20/100 to light perception i n the study eye. Patients were assigned randomly at time of enrollment to observ ation or surgical removal of blood and any associated CNV. A successful outcome was defined a priori as either improvement in visual acuity (VA), no change in V A, or a decline in VA of no more than 1 line (7 letters) from baseline to the 24 month examination based on an intent to treat analysis. Of 336 patients enro lled, 168 were assigned to each treatment arm; treatment arms were balanced by b aseline characteristics. Of 1501 expected examinations 3 months through 36 month s after baseline, 1370 (91%) were performed. Loss of ≥2 lines (≥8 letters) of VA occurred in 56%of surgery eyes, versus 59%of observation eyes examined at 24 months. Although severe loss of VA was not the primary outcome of interest, s urgery more often prevented such loss: 36%in the observation arm versus 21%in the surgery arm at the 24 month examination (χ2 P=0.004). Of initially phakic eyes, the cumulative percentage that had undergone cataract surgery by 24 months was 44%in the surgery arm, compared with 6%in the observation arm. Twenty se ven eyes (16%) in the surgical arm, compared with 3 eyes (2%) in the observati on arm, had a rhegmatogenous retinal detachment (RD). Submacular surgery as perf ormed in the SST Group B Trial did not increase the chance of stable or improved VA (the primary outcome of interest) and was associated with a high risk of rhe gmatogenous RD, but did reduce the risk of severe VA loss in comparison with obs ervation.
文摘To describe health related quality of life (HRQOL), overall and in patients w ith unilateral or bilateral choroidal neovascularization (CNV), in a clinical tr ial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age related macular degeneration (AMD). Randomized clinical trial. Eligible patients had untreated subfoveal CNV and AMD, best corrected visual a cuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a to tal subfoveal lesion size of ≤9.0 disc areas in the study eye. Health related quality of life data (the National Eye Institute Visual Function Questionnaire [ NEI VFQ], 36 item Short Form Health Survey [SF-36], and Hospital Anxiety a nd Depression Scale [HADS] ) and clinical data were collected at baseline and at 6 , 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence. Two yea r change in the NEI VFQ. Of 454 patients enrolled, 228 were assigned to observa tion and 226 to surgery. At baseline, median overall NEI VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation g roup had lost a median of 3 points (95%confidence interval [CI]:-6 to-2), a nd the surgery group gained a median of 1 point (CI:-1 to 3). The largest differe nce was observed for the mental health subscale, where the observation group los t a median of 5 points (CI:-5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2 year changes in NEI VFQ scores favored surgery by up to 10 points for unilateral cases and u p to 8 points for bilateral cases. No treatment difference in 2 year change was observed for the SF-36 physical component summary; 2 year change in the menta l component summary favored surgery by 2 points. Few patients (2%-4%) had HAD S definite anxiety or depression at baseline or at 24 months. Although HRQOL out comes were better in the submacular surgery arm than in the observation arm, sur gery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms.
文摘Purpose: To investigate the effects of photodynamic therapy (PDT) on juxtafove al choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a clinical patient material. Methods: Thirty eyes in 30 consecutive patients with AMD and a juxtafoveal CNV underwent PDT with verteporfin with standard par ameters. The patients were followed up for 12 months and retreated every 12 week s in the event of leakage from CNV. Nineteen patients (63.3%) had a predominant ly classic CNV, eight (26.7%) had a 100%occult CNV and three (10%) had a mini mally classic lesion. In 27 patients (90%) the lesion was ≤3 MPS (Macular Phot ocoagulation Study) disc diameters and ≤3 MPS disc areas. Results: There was a positive correlation between duration of symptoms and loss of visual acuity at 1 2 months (P < 0.02). For predominantly classic lesions, there was a positive cor relation between duration of symptoms and lesion size(P < 0.005). At 12 months, leakage had stopped after 3.3±0.9 treatments in 80%of the patients. Visual acu ity remained stable in 63.3%of the patients. Conclusion: Photodynamic therapy a ppears to be beneficial in patients with AMD and juxtafoveal CNV.
