Comparative Randomised Active Drug Controlled Clinical Trial ofa Herbal Eye Drop in Vision Syndrome

Eye and vision problems due to prolonged use of isconsidered as vision syndrome. It has been recognisedas an occupational condition and has significant effects onworkplace productivity. use is a high visuallydemanding task and may result in various symptoms likeeyestrain, headache, blurred vision, glare, irritation, burningsensation, watering, double vision, back pain, neck and shoulderpain, contact lens discomfort and changes in colour perception.Computer related visual problems are related with frequentsaccadic eye movements, continuous eye focusing (accommodation)and alignment demands. Various factors such as screen resolutionand contrast, image refresh rates and flicker (to focus andrefocus to keep images sharp) and screen glare may contribute tovisual discomforts. Prolonged staring, associated with reducedblink rate results in evaporation of tear film, leading to dryeye and reduces the focusing ability still further leading toblurred vision and headache. Other factors like workingdistance, posture, height of screen, illumination mayalso contribute to visual problems.

Material and Method

This study was a double-blind randomised active drug-controlledclinical trial. Identical vials with code number containingeither itone, placebo or tears substitute (tears plus) were usedin this study. Informed consent was taken from each patient toparticipate in this study. Patients using for at least3 hours / day having symptoms of irritation, foreign bodysensation, watering, redness, headache, eyeache and signs ofconjunctival congestion, mucus debris, corneal filaments,staining, lacrimal lake were included in this study. Patientswith uncontrolled hypertension, diabetes, impaired renalfunction, clinically relevant hepatic and cardiac dysfunction,pregnant and lactating women were excluded from this study.Ocular examination included detailed history regarding computeruse, Snellen's visual acuity, refraction, intra-ocular pressureassessment, anterior segment examination, orthoptic work-up.Special tests like Schirmer test, tear film break-up time (BUT),fluorescein staining, rose Bengal staining were conducted ineach patient.

All the patients having symptoms and signs of visionsyndrome were instructed to instill one drop of itone, tearssubstitute or placebo four times daily in each eye for 6 weeks.Patients were asked to come for follow-up at 2 weeks interval toobserve any change in objective and subjective findings.Side-effects if any were also noted.

The data were arranged for statistical analysis. The outcomevariables



were scored by means of mean and standard deviation.The mean scores were analysed to assess the significance ofdifference in between multiple groups (A, B, and C) by Kunshal -Wallis test ( non-parametric equivalent of ANOVA) and assessmentof significance of difference in means scores between individualgroups were done by Mann - Whitney U test ( non-parametricequivalent of unpaired 't' test). P value < 0.05 was consideredas statistically significant.

Observations

A total of 120 cases attending outpatient department of SusrutEye Foundation & Research Centre were studied. Out of 120 cases,39 received itone, 41 cases received tears substitute and 40cases received placebo. There were 45 females and 75 males.Average ages of patients were 28.24 years for itone group, 27.54for tears substitute group and 27.64 for placebo group.Comparison was done between baseline symptoms and symptoms at6weeks. Comparison was also made between each group at 6 weekstime. Results are shown in Table 1. In this study the herbal eyedrop was found significantly better than placebo (þ<0.01). Nostatistically significant difference was found between itone andtears substitute and both are almost equally effective inreducing symptoms in vision syndrome. No side-effectsfrom any of the drugs were noticed in this study.

Discussion

Computer vision syndrome is a rapidly increasing problemworld-wide due to widespread use of computers in almost everyfield in modern life. And as it is a high visually demandingtask, vision problem and symptoms have become very common intoday's work-place. Prolonged use of is associated withreduced blink rate to maintain a clear image. This inassociation with compromised visual environment gives rise tovarious symptoms like eyestrain, headache, blurred vision,glare, irritation, redness, watering and neck and shoulder pain.

Several studies have reported the effectivity of tearssubstitutes in dry eye and vision syndrome. Biswas etal found that itone was significantly effective than placebo inthe management of dry eye syndrome. Biswas et al11 also reporteda comparative clinical trial of an herbal eye drop with tearssubstitute and placebo. They have found that itone wassignificantly better than tears substitute and placebo incomputer vision syndrome.

In the present study it has been observed that itone issignificantly better than placebo in reducing symptoms incomputer vision syndrome and also it is comparable with tearssubstitute in reducing symptoms (the difference is notstatistically significant). It is concluded that itone is aneffective drug in reducing symptoms in vision syndrome.Visithttp://www.herbalhealthcure.com/product_info.php/pName/itone-eye-drops-for-eye-care

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