|Year : 2004 | Volume
| Issue : 3 | Page : 227-31
Verteporfin therapy for myopic choroidal neovascularisation in Indian eyes (one year results).
N Hussain, T Das, U Vashist, K Sumashri
L V Prasad Eye Institute, Hyderabad, India
|Date of Submission||02-Mar-2004|
|Date of Acceptance||11-Jun-2004|
L V Prasad Eye Institute, Hyderabad
Source of Support: None, Conflict of Interest: None
PURPOSE: To investigate the 12 months' follow-up outcome of photodynamic therapy (PDT) with verteporfin for CNV in pathologic myopia in pigmented eyes of patients from the Indian subcontinent. METHODS: Nine eyes of 9 consecutive patients were included in the study. Patients with a spherical equivalent of - 6 diopter or more and baseline visual acuity of 6/60 or better were included. All patients received ETDRS visual acuity test (including letter acuity) and fluorescein angiography both before and after PDT. All patients had at least 12 months of follow up. RESULTS: The final visual acuity was unchanged 8 eyes (88.8% had VA of 6/30 or better) at the end of 12 months. Six eyes (66.7%) lost < or = 8 letters and three eyes (33.3%) lost < or = 15 letters at the end of 12 months from the baseline. CONCLUSION: Photodynamic therapy with verteporfin for subfoveal choroidal neovascularisation secondary to high myopia tends to stabilise the vision at 12 months follow up in Indian eyes. Longer follow up is necessary to understand the natural history of CNV treated with PDT in high myopia in Indian eyes.
Keywords: Myopia, choroidal neovascularisation, verteporfin, subretinal fibrosis, Indian eyes
|How to cite this article:|
Hussain N, Das T, Vashist U, Sumashri K. Verteporfin therapy for myopic choroidal neovascularisation in Indian eyes (one year results). Indian J Ophthalmol 2004;52:227
|How to cite this URL:|
Hussain N, Das T, Vashist U, Sumashri K. Verteporfin therapy for myopic choroidal neovascularisation in Indian eyes (one year results). Indian J Ophthalmol [serial online] 2004 [cited 2020 May 28];52:227. Available from: http://www.ijo.in/text.asp?2004/52/3/227/14586
High myopia of more than 6 diopters affects 2% of the general population and 27-33% of all myopic eyes. Myopic chorioretinal atrophy affecting the macula and choroidal neovascularisation (CNV) are common causes of visual loss in high myopes. It is often bilateral and irreversible, and is estimated to cause an average of 17 years of legal blindness., The longterm visual outcome of myopic CNV is extremely poor. More than 90% of persons with CNV end up with visual acuity of 6/60 or less in ten years' time. Additionally, myopic CNV invariably leads to progressive chorioretinal atrophy. The longterm treatment goal of myopic CNV is to not only arrest CNV but also to prevent development of chorioretinal atrophy. Various therapeutic approaches have been attempted in the management of myopic CNV; each has its own benefits and drawbacks. ,,,,,,,
Two-year results of randomised placebo-controlled clinical trial (VIP report 1 and 2) of photodynamic therapy with verteporfin for subfoveal CNV in pathologic myopia have shown benefits in the verteporfin group., 36% of patients in the verteporfin treated group lost 8 letters (1.5 lines of ETDRS acuity) compared to 51% in the placebo treated group (P=0.11) at 24 months. This was statistically significant (first year following treatment) and clinically significant (two years following treatment).
In this study we evaluated the 12 months' follow up outcome of photodynamic therapy with verteporfin for CNV in pathological myopia in pigmented eyes of patients from the Indian subcontinent.
| Materials and Methods|| |
All the data were collected prospectively in a standardised manner and analysed retrospectively. The study period was from May 2001 to September 2002. Informed consent was obtained from all the participating patients prior to the photodynamic therapy.
The inclusion criteria were:
1. Best corrected visual acuity ž 6/60;
2. Myopia of ž 6 diopter spherical equivalent
3. Fundus changes characteristic of chorioretinal atrophy, lacquer cracks, posterior staphyloma;
4. Age ž 18 years
5. No history of previous laser in the macula;
6. Fluorescein angiographic documentation of CNV,
7. No intraocular surgery in the past 3 months, and
8. No other ocular disorders possibly causing CNV including angioid streaks and age-related macular degeneration.
The standard pretreatment evaluation included a detailed medical history, visual acuity measurement with ETDRS chart, Amsler grid test, slitlamp biomicroscopy, fundus examination (+ 20 D; + 90 D), colour fundus photographs and fundus fluorescein angiography (FFA). Visual acuity was tested in undilated pupil using ETDRS chart at 4 metres and 2 metres distance. This was done with the patient's own spectacles and a new refraction (if different from the spectacles). Each eye was tested separately. The near vision was tested after the distance vision. Amsler grid test was performed in each case using a black and white Amsler chart evaluated at a distance of 30 cm wearing the best-corrected spectacles for near.
FFA was done by a trained and certified optometrist using a confocal scanning laser ophthalmoscope (Heidelberg Retinal Angiograph, Heidelberg Engineering Inc.). 3 ml of 20% sodium fluorescein dye was used. The image frames were acquired at 0 - 1 minutes, 3 - 5 minutes, 7 minutes and 10 minutes at 30° field. The angiographic images were analysed and greatest linear diameter (GLD) calculated using the software available in the HRA system. Fundus photograph were taken at the 30° field focusing on the macula and the disc using a digital fundus camera (Carl Zeiss Jena, Germany).
The follow-up schedule for the patients was every month for 3 months, and every 3 months for the next 9 months. All the above mentioned tests were repeated on every follow up examinations.
Diagnosis and PDT treatment criteria were followed according to the protocols of the VIP study and TAP study respectively. As per our PDT laser system (Carl Zeiss Jena, Germany), the GLD of the entire lesion was less than 5400 microns on the FFA. Any hypofluorescence from blood contiguous with the CNV and/or a serous detachment of the retinal pigment epithelium were also included in the retreatment besides the active leaking areas. The staining due to scar tissue, which did not leak at its boundaries, was not included in the GLD. The retreatment was also based on the leakage pattern and size of the lesion compared with the pretreatment FFA.
A diode laser of 689 nm Zeiss laser slitlamp delivery system was used. The system was tuned to deliver 50 mJ/ cm2 of energy at an intensity of 600 mW/ cm2 over 83 seconds. Following the TAP protocol, the dose of verteporfin was calculated and diluted with 5 % dextrose in water and prepared up to 30 ml. The drug was infused at the rate of 3 ml per minute over a period of 10 minutes and 5 minutes later, a laser light was applied over the lesion area for 83 seconds. Patients were instructed to avoid direct bright light for 48 hours and wear sunglasses with low transmittance for 7 days.
Stabilisation of vision was defined as baseline vision ! 5 letters in the ETDRS vision chart tested at 4 metres. Improvement and reduction in vision was defined as a change in vision of 10 or more letters in the ETDRS vision chart at 4 metres.
| Results|| |
During the study period of 12 months, 54 eyes of 54 patients received photodynamic therapy with verteporfin. Fifteen of these eyes had myopic CNV secondary to pathologic myopia. Nine of 15 patients were included in the study as these patients had completed 12 months of follow up at the end of the study period, fulfilling the inclusion criteria [Table - 1]. The age ranged from 28 to 58 years (average: 43.4 ± 9.76 years). Six patients (66.7%) were male and right eye was affected in 5 (55.6%) individuals. The spherical equivalent ranged between - 6.0 D and - 25 D (mean: -11.97 D ± 6.26). Eight eyes (88.9%) had subfoveal CNV and one eye (11.1%) had juxtafoveal CNV very close to the fovea.
The primary treatment GLD varied from 570 microns to 2320 microns (mean: 1582.2 ± 501.04). The retreatment GLD varied from 570 microns to 2100 microns (mean: 1812.2 ± 773.9). Seven of 9 eyes (77.8%) received the second treatment in the second month of follow up; one eye (11.1%) received the second and another eye (11.1%) received the third treatment in the third month, 2 eyes (22.2%) received the third treatment in the sixth month follow up and one eye (11.1%) received the fourth treatment at the 12th month of follow up. Thus, 8 of 9 eyes (88.9%) required at least two treatments - 5 eyes (55.6%) received two treatments and 3 eyes (33.3%) had three treatments [Table - 1], [Figure - 1].
Three patients were advised to have re-treatment at 1, 3, and 6 months respectively, but did not consent for financial reasons. One of the patients received re-treatment 4 weeks later with decrease in the visual acuity by one line and the other two were stable at the next follow-up visit 4 weeks later.
Visual Acuity Outcome
All eyes showed 5 or more letters improvement at month one. Seven eyes (77.8%) and 5 eyes (55.6%) were either stable or showed 5 letters improvement at month 3 and 12 respectively. Reduction of visual acuity was not seen at month one. Two eyes (22.2%) showed 5 letters loss at month 3. At one year follow up one eye (11.1%) showed 5 letters loss ( 1 line); two eyes (22.2%) had 10 letters loss ( 2 lines) and one eye had ž 15 letters loss (ž 3 lines). Thus, four eyes (44.4%) had ž 1.4 ETDRS lines of improvement at the 12th month and two eyes (33.3%) had ž 2 ETDRS lines of deterioration from the baseline. Analysing as per the VIP, 6 eyes (66.7 %) had 8 letters loss and 3 eyes (33.3 %) had 15 letters loss at the end of 12 months' follow up.
The presenting visual acuity was 6/12 or better in 3 eyes (33.3%); 6/15 - 6/30 in 4 eyes (44.4%) and 6/38 - 6/60 in 2 eyes (22.2%). At month 12, three eyes (33.3%) had 6/12 or better and 5 eyes (55.6%) had 6/30 or better. The overall VA was maintained in 8 eyes at month 12.
Fluorescein angiography images of all the patients were analysed for change of size and characteristics of lesion, presence of collateral damage or enlargement of chorioretinal atrophy and any notable adverse changes during the follow-up period.
At 12 months, the lesion size increased in five eyes (55.6%) (mean increase: 754 ± 351.18 microns) and the lesion size decreased in 4 eyes (44.4%) (mean decrease: 412.5 ± 287.09 microns). The increase in the lesion size and associated subretinal fibrosis [Figure - 2] and [Figure 3] did not affect the visual acuity. Presence of either areas of significant retinal pigment epithelium (RPE) alterations around the CNV or chorioretinal atrophy in one or other quadrants was indicative of collateral RPE damage within the area of the laser spot [Figure - 2]. This was seen in 5 of 9 eyes (55.6%) at the end of the follow up [Table - 1]. But this did not alter the clinical course associated with significant visual deterioration. Of these, 3 eyes had improved vision, which was unchanged in two eyes. A well circumscribed RPE collateral damage was not seen in the present study.
| Discussion|| |
The visual deterioration in high or pathologic myopia are due to development of degenerative myopic chorioretinal atrophy, choroidal neovascularisation, amblyopia or the combinations. 5 to 10% of this population can have a sight-threatening complication of CNV. The natural history is progressive visual loss. Treatment is aimed at closure of the CNV and prevention of progression of chorioretinal atrophy around the CNV.
The VIP study has shown the beneficial effect of photodynamic therapy with verteporfin for myopic subfoveal CNV at 12 and 24 months of follow up.,  The clinical trial demonstrated that verteporfin therapy can increase the chance of stabilising (< 8 letter loss) or improving vision compared to placebo therapy at least at one and two-year follow up., Our study has shown a similar trend. Six eyes (66.7 %) had a loss of 8 letters and 3 eyes (33.3 %) had a loss of 15 letters at the end of 12 months of follow up.
The important feature of angiographic analysis was the negative clinical correlation of the subretinal fibrosis with change in lesion size and vision following PDT. In our study population the scar formation following PDT did not adversely affect the vision. Subretinal fibrosis following PDT in myopic CNV eyes has been reported earlier.  We also noted an increase in CNV size (mean: 754 ± 351.18 microns) at 12 months in 55.6% of the eyes though this did not affect the vision. Appearance of subretinal fluid after PDT does not necessarily imply a reduction of vision. A longer follow up is necessary to study the natural history following repeated PDT.
Collateral damage following PDT is known to occur in experimental animals. ,  Collateral damage was seen in 5 eyes of 9 patients but this damage was mostly focal in nature. The changes were seen in an extra quadrant if there was a baseline RPE alteration around the lesion. We did not notice any concentric RPE atrophy as reported by Wachtlin et al.
The present study also shows that 8 of 9 eyes (88.9%) required at least two treatment sessions. Of these, 5 eyes (55.6%) required single retreatment and 3 eyes (33.3%) required two retreatments. The two weaknesses of our study are the small sample size and short (12 months) follow up. Despite this, our findings show similar trends as the large study from North America and Western Europe. Based on our limited experience we conclude that photodynamic therapy using verteporfin is useful in myopic CNV in Indian eyes.
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[Figure - 1], [Figure - 2]
[Table - 1]
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