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DIABETIC RETINOPATHY SCREENING WITH NON MYDRIATIC RETINOGRAPHY: ABOUT 150 CASES
Authors: Chebbi A, Hachicha F, Lajmi H, Zgolli H, Malek I, Bouguila H, Zghal I, Nacef L.
Department A of Hedi Raies institute-Tunis
INTRODUCTION 
Diabetic retinopathy (DR) is the leading cause of blindness among adults under the age of 60 years in developed countries.
The Diabetic microangiopathy is an insidious disease that become symptomatique at stage of complications. That is why a rapid and reliable retinal screening examination helps to reduce the incidence of blindness because early detection of diabetic retinoapthy leads to an effective treatment [1].
Dilated Fundus examination is a routine part of every examination of the eye.
However, many patients delay their examination to avoid blurred vision after dilatation.
A number of studies have demonstrated the benefits of diabetic retinopathy screening using a non-mydriatic retinal digital camera. 
Our work aims to study epidemic features of diabetic retinopathy and to discuss the interest of using non mydriatic retinography for mass screening.
MATERIAL AND METHODS 
We carried out a prospective cohort study including 150 patients (300 eyes) from January to September 2013 in Department A of Ophthalmology Hedi Raies institute of Tunis, Tunisia.
We excluded patients having a regular monitoring and those who�s DR is already diagnosed and treated.
The requested informations were: 
Age,  type and duration of diabetes, the treatments taken , recent modifications of the therapeutic protocol, general history (hypertension, lipids disorders , nephropathy..) , ophthalmologic history, causes of consultation and ophthalmological signs ( blurred vision, dyschromatopsia..)
The best corrected visual acuity
Anterior segment examination (iris new vessels, cataract...)
A non mydriatic retinography was accomplished for all of patients in the required conditions (dark room, qualified operator�.).
All images were acquired with a KOWA retinograph which permits to capture nasal and temporal part of the fundus for each eye covering 20� to 40�. Retinal images are uploaded to a data processing system for the ophthalmologist review. The number of images varies  by patient from 3,5 and 7 for each eye ( diagram 5)
The pupils were then dilated with mydriatic drops, a combination of tropicamide 0.5% (Mydriaticum�) and phenyephrine HCL 10% (Neosynephrine�)  and a biomicroscopic  examination was performed with  a three-mirror lens. 
The image quality was analyzed according to three criteria: the definition of the image, the image surface and centromaculaire region. For each criterion, the image quality was classified into 2 groups: parsed or unparsed.
The image quality was classified from 1 to 5 according to a descending order:
- Grade 1: very bad 
- Grade 2: bad
- Grade 3:Good
-Grade 4: Very good 
-Grade 5: Excellent
We classified lesions according to EDTRS and ALFEDIAM scores as:
-No retinopathy, 
-Non-proliferative retinopathy (mild, moderate, or severe)
-Proliferative retinopathy (mild, moderate, severe or complicated)
-Diabetic edema was classified as absent or present.
Data were coded, entered and analyzed using EPI info 6:
We described continuous variables using mean and standard deviation
 We analyzed the sensibility and specificity of non mydriatic retinography in comparison with 3 mirrors examination. 
RESULTS 
A total of 150 patients were included. Of these, 37.33 % (56 patients) were male and 62.66% were female (94 patients), with a sex ratio of 0.59. Their ages ranged between 14 and 83 years, with a mean age of 57 years. 82% of patients had type 2 diabetes and 18 % of them had type 1. The disease was well-balanced at only 23.33 % of cases.
The Duration of diabetes was less than 5 years in 14% of cases (21 patients), between 5 and 10 years in 56% of cases (84 patients) and more than 10 years  in 30 % of cases. An associated hypertension was found in 63.33%, lipid disorder in 51.33% and urinary microalbumine in 17.33% of cases.
Distance visual acuity in the right eye was < 1/10 in 9.33 % of cases, had ranged between 2/10 and 5/10 in 48.66 % of cases and between 6/10 and 10/10 in 42% of cases. For the left eye distance visual acuity was < 1/10 in 6 % of cases, had ranged between 2/10 and 5/10 in 38 % of cases and between 6/10 and 10/10 in 56 % of cases.
Near visual acuity was P2 in 37.33 %, P4 in 26%, P6 in 17.33% and P8 in 19.33% for the right eye. For the left eye, it was P2 in 25.33 %, P4 in 42%, P6 in 18.66% and P8 in 14% of cases. A cataract was found in 56 patients (18.33%).
The 3 mirrors fundus examination showed no DR in 23% and a DR all stages combined in 77% cases. 
In non mydriatic retinography, 59.33% of cases (89 patients) have required 3 photos, 30 % of cases (45 patients) 5 photos and 10.66% of cases 7 photos (figure 1). 
For the right eye, Grade 2 was found in 45.33% of cases (68 eyes) and it was around 66% of cases for the left eye (48 eyes) (figure 2). The quality of images was acceptable for the majority of eyes and it decreased with the age of patients (figure 3).
We noticed that the myosis did not affect the quality of images. Indeed, most of  photos were grade 1 or 2  and we  have not resorted to dilatation only in 62 eyes (figure 4).
With this technique we found no DR in 23% for the right eye and 25.33% for the left eye. DR was found in 73.67% of cases.
Of the patients with DR, 58.66 % of cases had non-proliferative DR in the right eye and 61.33% in the left eye (figure 5). 4.66% of cases had proliferative DR in the right eye versus 5.33 % in the left eye (figure 6). 
The right eye was free of diabetic maculopathy in 80.66 % of cases and presented a macular edema in 10 % of cases while the macula in the left eye was normal in 84.66% of cases and edematous in 7.33% of cases.
According to data from the ophthalmologic examination and results of non mydriatic retinography, the delay of appointments was close in 68% of cases and delayed in 32% of cases.
In our study, by comparing the results of the non-mydriatic fundus and indirect ophthalmoscopy with mirror 3 examination, we noticed that for the right eye that number of true positive was 104 and number of true negative was 33. The number of false negative was 5 and the number of false positive was 8 (table I). According to these results, the sensitivity of the fundus with respect to the indirect ophthalmoscopy was 92.85% and the specificity of the fundus with respect to the indirect ophthalmoscopy was 86.84 %.
For the left eye, we noticed that for the right eye the number of true positive was 110 and number of true negative was 29. The number of false negative was 9 and the number of false positive was 2. (table II) . According to these results, the sensitivity of the fundus with respect to the indirect ophthalmoscopy was 92.43 % and the specificity of the fundus with respect to the indirect ophthalmoscopy was 93.54 %. 
DISCUSSION:
Diabetic retinopathy (DR) remains the leading cause of blindness among adults under the age of 60 years in developed countries. The world health organization estimate the number of diabetics to be more than 180 millions around the world, this number would double in 2030.
The prevalence of DR varies by country; it is of 17.6% in India [2], 33.2% in the U.S.A [3] and 28.9% in non-Indigenous�Australian [4].
Our series showed a prevalence of 73.67% diagnosed by non mydriatic retinography which is a high percentage compared with other Tunisian authors such as Ben Hammouda (44%) [5]
 This diversity might be explained by the difference of used methods, the techniques of diagnose and the variability of the studied populations  especially age, type and duration of diabetes, the date of the first consultation and the high level of patients with degenerative complications.
Till now, two traditional screening methods are available: the ETDRS seven-standard-field stereoscopic protocol and the conventional fundus examination after dilatation by the ophthalmologist. 
The seven standard stereoscopic photographic fields allows studying a large surface of retina but must be performed after pupil dilatation. However, it requires knowledge of the level of the position of the camera according to the different fields, a long process that requires a trained operator with a high cost that limits its use for screening at certain specialized centers [6,7].
The fundus examination by direct or indirect ophthalmoscopy, is not very interesting for screening. In fact, the blurred vision due to pupillary dilatation may explain why patients delay or miss their appointment.
In fact, annual screening recommended by the ALFEDIAM [8] in 1996 and the ANAES recommendations are insufficiently practiced [9]. The CNAMTS survey showed that less than 50% of diabetes patients included in these studies consulted an ophthalmologist during the previous year [10], hence the need to optimize screening methods to overcome their shortcomings [6,7].
Non mydriatic retinal cameras is a new technology based on combination between cameras and computer system allowing capturing, processing and visualization fundus images which are uploaded to a data processing system for the ophthalmologist review.
These cameras do not require dilatation, meaning that medical control is not necessary, dilatation time (20 min) is saved, blurred vision is avoided and the cost is minimized. Besides, all images are saved allowing specialist to consult them whenever it is necessary or to transfer them safely.
Retinography with conventional cameras (35 mm) is a technique used since many years and considered as a screening methods as same as ophthalmoscopy according to Australian, American, New Zealand, Scottish and English recommendations [11,12]. It is considered as the reference and in case of failure, the ophthalmoscopy is performed.
Non mydriatic cameras is used till the 80ies, with a sensibility of 60 to 90% in comparison with conventional examination techniques, the specificity however is inferior to the ophthalmological examination. 
In our study, the concordance between non mydriatic retinography and indirect ophthlmoscopy was 92% in both eyes. In the other hand, the specificity was of 86.84% and 93.54% for the right and the left eye.
We note generally that non mydriatic retinography has nearly the same sensibility but slightly lower specificity as indirect ophthalmoscopy, which is acceptable for a screening test.
This relationship was demonstrated also in our work. In fact, in case of the right eye,the sensibility of non mydriatic retinography was of 92.85% in comparison with indirect ophthalmoscopy. The specificity however was slightly lower with 86.84%.
The performance of this exam depends on the number of photographed fields which vary from 1 to 5 and on performing either the seven standard stereoscopic photographic fields or the conventional fundus examination after dilatation by the ophthalmologist after pupil dilatation [7,13-16].
There was a study comparing in term of sensibility the non mydriatic retinography with 2, 3 or 4 fields in 98 patients to the EDTRS reference exam with 7 fields and concluded that the sensibility was of 95.7 % independently of the number of fields. However, the specificity decreased from 78.1% to 65.6 % and the sensibility increased from 95.7% to 97.6% when the number of shots decreased from 2 to 4 [17,18].
The DR screening protocols were established and differ across regions. In Scotland, it includes 3 steps: first, 45� posterior pole images without dilatation, then in case of failure, we repeat the same exam but with dilatation. Otherwise indirect ophthalmoscopy is performed.
According to French recommendations 2007 [17], DR protocol must contain 2 images of 45� in both eyes, one is centered on the macula the other on the optic disk, a third field temporal or nasal is facultative.
In our work, the number of images was 3, 5 or 7 by eye. Our patients required 3 images in 59.33% for the right eye and 60.66% for the left eye, joining the French recommendations.
In Scottish DR screening program, 3 levels of interpretation are provided: first, we must precise the absence or the presence of DR, second, we determine images that must be send urgently to a specialist and finally an ophthalmologist must indicate whether the patient necessitates a monitoring by a specialist [17].
Recommendations of experts in 2006 [7] estimates that screening strategy must allow the diagnose of severe forms of DR. Afterword, the delay of sending is less than 2 months in case of non proliferative DR and less than 2 weeks if the DR is proliferative [17].
CONCLUSION: 
Diabetic retinopathy (DR) is a diabetic microangiopathy that remains the leading cause of blindness in adults between 20 and 60 years age old.
The precocious diagnose by a pertinent screening strategy is necessary to avoid retinal complications.
The non mydriatic retinography is is currently considered as the reference method of diabetic retinopathy screening. Indeed, it allows adhesion of diabetic patients to the screening program and the possibility of multi centric data exchange between physicians and archiving. 


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Figure 2: Quality of photos taken for each eye by non mydriatic retinography
Figure 3: Quality of photos depending on age
Figure 4: Quality of photos depending on dilatation
Figure 5: Number of non proliferative retinopathy for each eye by non mydriatic retinography.
Figure 6: Number of proliferative retinopathy for each eye by non mydriatic retinography.


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