ISSN: 0975-8585

Research Journal of Pharmaceutical, Biological and Chemical

Sciences

Comparison of Effect of Single Drop of Tropicamide 0.8% and Phenylepherine

5% versus Multiple Drops on Cycloplegia and Near Point of Convergence
(NPC).
Niharika Shetty*, Sutapa Roy, Mahabaleshwar, and Lokesh HM.
Department of Ophthalmology, Sri Siddhartha Medical College, Tumkur, Karnataka, India.

ABSTRACT

The quality of an intraocular examination for intra-ocular surgeries like cataract surgery, depends on
adequate pupil dilatation and for refraction depends on the cycloplegia attained by the drug. Mydriatics are
also very commonly used as cycloplegic drug in early presbyopes and in adults attending ophthalmologic OPD
for the asthenopic symptoms for detection of latent refractive errors. Strong cycloplegic drugs retain their
effect for longer duration and hence not very acceptable to patients as it hampers their routine daily activities,
hence drugs with shorter duration of action and acceptable cycloplegia is desired in adults requiring refraction
assessment for asthenopic symptoms. To assess the cycloplegia and convergence on single and multiple
applications of the drug.2)To assess the patient for any adverse drug reactions on application of the drug. A
hospital based randomised controlled trial of minimum 100 cases in each group,who presented to the
department of Ophthalmology ,Sri Siddhartha Medical College,Tumkur between November 2011 to June 2013
were taken. After recording the demographic data, a brief systemic examination for, base line pulse and blood
pressure were done. Pupils were assessed for direct and indirect light reflexes and the initial pupil size was
recorded using pupil gauge. Accommodation and convergence were assessed using Livingstone’s gauge/RAF
rule. The patients were randomly allocated into 2 groups, group A was administered single drop and group B
was administered multiple applications (at intervals of 10 minutes for a total of 40 minutes) of a combination
of 0.8% Tropicamide and 5% Phenylephrine. The pulse, blood pressure, pupil size, convergence and cycloplegia
were assessed every 10 minutes for a total duration of 40 minutes. The near point of accommodation after 20
minutes was found to be also significantly lower in the multiple group as compared to the single group(23.95 ±
2.29 cm after 20 minutes in single group; 23.16 ± 2.30 cm after 20 minutes in multiple group; p-value 0.016
was significant). But the final near point of accommodation after 40 minutes in both the single and multiple
applications groups were similar(34.35 ± 1.77 cm in single group; 34.49 ± 1.53 cm in multiple group; p-value
not significant). The increase in the near point of convergence after 40 minutes was comparable both the
groups , but there was no difference in single vs multiple group. The increase in the heart rate was not found
to be significant in both the groups. The increase in the systolic blood pressure was not significant in both the
groups. Tropicamide- phenylepherine combination drop can be an effective cycloplegic in adults, whose
accommodation reserve are weaker compared to children. The effect of cycloplegia don’t differ with the
number of instillations. Also no systemic adverse effects were noted with the drops .
Keywords: Tropicamide , Phenylepherine ,Cycloplegics, Convergence, Accomodation

*Corresponding author

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INTRODUCTION

The quality of an intraocular examination for refraction as well as intra-ocular surgeries like cataract
surgery, depends on adequate pupil dilatation [1].

Mydriatics are also very commonly used as cycloplegic drug in early presbyopes and in adults
attending ophthalmologic OPD for the asthenopic symptoms for detection of latent refractive errors.
Parasympathetics as well as sympathomimetic drugs have been used to dilate the pupil.

The most desired effect of these cycloplegic agents is their effect on the ciliary muscles of the eyes,
which are paralyzed to bring about relaxation or a complete elimination of accommodation, that is,
cycloplegia.

Cycloplegia is the paralysis of the ciliary muscles achieved by blocking the muscarinic receptors normally
stimulated by the release of acetylcholine from the nerve endings of the parasympathetic system .Cycloplegia
is always accompanied by mydriasis (although mydriasis is not always accompanied by cycloplegia [2].
Cycloplegic drugs reduce accommodation thus making latent refractive errors manifest [3,4].

A satisfactory prescription for glasses may be given only after accurate refractive assessment of the
eye. The punctum remotum, or the far point of the eye, is the conjugate focus of the retina when the eye is in
a non-accommodative state. Clinical methods to suspend accommodation during the examination are needed.
This can be achieved in one of two ways:

 By inserting stronger convex lenses known as the “fogging technique”; by paralyzing the
accommodation with drugs, “cycloplegia.
 Blockade of the cholinergic system dilates the pupil (mydriasis) and relaxes the ciliary muscle,
decreasing accommodation (cycloplegia )

The cilliary muscle may have a minor adrenergic innervation, with stimulation decreasing accommodation.

Accommodation Reflex

Accommodations include (l) convergence of the eyes, (2) thickening of the lenses, and (3) pupillary
constriction. Convergence keeps the object focused on the fovea for maximum visual acuity. As the object is
brought closer, light rays become less parallel, and the refractive power of the lens must be increased to focus
the image on the retina. The lens becomes more spherical, thereby increasing its refractive power. In order to
increase the depth of focus the pupils constrict [5].

1811 when William Wells, a London oculist, discovered that a patient whose pupils were dilated with
Atropine had partial ptosis and a failure of accommodation. The refractive state also changed from slightly
myopic to slightly hyperopic [6].

Cycloplegic Agents

Cycloplegic agents are drugs that act by antagonizing the muscarinic action of acetylcholine. They do
so by blocking its action at structures innervated by postganglionic parasympathetic nerve fibres. These agents
paralyse the constrictor pupillae as well as the ciliary muscle, causing mydriasis as well as cycloplegia [7].

For many years, atropine was the only cycloplegic agent available. To bring about full cycloplegia in
children, it had to be instilled two or three times daily for three days prior to cycloplegic refraction. The
resulting cycloplegia persisted for seven to ten days and the accompanying mydriasis lasted as long as two
weeks [8].

Homatropine is a semi-synthetic alkaloid, the cycloplegic effect begins in a matter of 45-60 minutes
[9].

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Cyclopentolate (cyclogyl) is a short acting cycloplegic agent available in 0.5 and 1.0 percent solutions.
With this agent, cycloplegia occurs within 30-45 minutes and persists for up to 24 hours. Even though it does
not yield as complete cycloplegia in children as atropine, it is considered a suitable alternative to atropine for
children, even under the age of six. Reports of central nervous system effects following the use of
cyclopentolate include confusion, ataxia and personality changes [9].

Tropicamide (Mydriacy I) is also a short acting cycloplegia available in 0.5 and 1.0 percent solutions.
For young adults, three or four drops of the 1.0 percent solution, separated by a few minutes, will bring about
full cycloplegia, and recovery occurs in two to six hours. Davies (1989) considers tropicamide inadequate for
producing cycloplegia in children [9,10]. According to Lyle and Hopkins (1977), reports of adverse reactions to
tropicamide are made conspicuous by their rarity. In addition to its use as a cycloplegic, tropicamide is widely
used as a mydriatic agent [10].

Choice of a Cycloplegic Agent

In children below the age of six years, complete cycloplegia can be obtained only with the use of
atropine. However, the use of atropine is attended by a number of complications.

When an agent other than atropine is used for cycloplegic refraction, it is not considered necessary to
subtract a “tonus allowance” as it is when atropine is used. On the basis of Davies (1989) report, that twenty
patients between the ages of 10 and 14 who were refracted under tropicamide had an average amount of
residual accommodation of 3.56D, it is recommended that cyclopentolate (1 percent) be used for children.
Tropicamide, however, will induce an adequate cycloplegic effect in adults.

Indication for Cycloplegic Refraction

Among the diagnostic pharmaceutical agents that ophthalmologists use, cycloplegic agents are
indicated in far fewer cases than either mydriatic agents or anesthetics. Mydriatics are used frequently by
practitioners who use binocular indirect ophthalmoscopy and fundus photography, while topical anesthetics
are used routinely by practitioners who perform applanation tonometry and gonioscopy. Cycloplegic refraction
is in fact necessary for only a small percentage of patients [11].

Commonest indications being, 1) When a child (often a pre-scholar) is seen with a convergent
strabismus, and 2) For young adults between the ages of 16 and 40, latent hyperopia presents with asthenopic
symptoms.

Tropicamide (1 percent) is considered to be the best cycloplegic agent because it has virtually no side
effects,especially for adults.

Cycloplegics are also used in 1) ciliary spasm 2) uveitis 3) occlusion

Factors Affecting the Choice of a Cycloplegic

Age: the amplitude of accommodation in children is always greater than that of adults.

Pigmentation of the Iris: it is quickly evident to an examiner with much clinical experience that greatly
pigmented irides, such as are seen in non-Caucasians, will dilate with greater difficulty than the lightly
pigmented eye.

Occupation: excluding the young child, in using cycloplegic agents in therapeutic for diagnosis the more
committed or in-demand an individual is, the greater the need for an agent with rapid recovery.

Tropicamide

Tropicamide thus belongs to the parasympatholytic drug group and is an antimuscarinic agent that
acts as a competitive antagonist to acetylcholine and other muscarinic drugs. The actions of acetylcholine are

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inhibited by tropicamide at the structures innervated by the postganglionic cholinergic nerves of certain
smooth muscles.

Tropicamide and all others in the antimuscarinic class block the action of the sphincter muscle of the
iris and the ciliary muscles of the lens to cholinergic stimulation, thereby dilating the pupil and inhibiting
accommodation (cycloplegia).

When a 0.5 percent or a 1 percent solution of tropicamide is used, mydriasis is rapid in onset reaching
its peak in 15– 30 minutes with a return to normal occurring in 8–9 hours. Tropicamide’s cycloplegic action is
relatively weak reaching its maximum effect after 25 minutes and with full amplitude having returned after 6
hours (Vale and Cox, 1984) [10].

Precautions

 Tropicamide should not be used in patients with a narrow angle glaucoma since it may raise intra-
ocular pressure and precipitate an acute attack.
 As with other antimuscarinic agents, tropicamide should be used with caution in conditions
characterised by tachycardia such as thyrotoxicosis, heart failure, and in cardiac surgery where it may
further accelerate the heart rate. Care is required in patients with acute myocardial infarction as
ischaemia and infarction may be made worse.

Adverse Reactions

Systemic side effects

BODY: Anaphylaxis

CVS: Transient brachycardia followed by tachycardia, with palpitations and arrhythmias.

CNS: Drowsiness and sedation, inability to concentrate and fatigue, psychotic reactions and behavioural
disturbances – more common in children than adults.

RESP: Dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions,
bronchospasm.

GIT: Difficulty in micturition, as well as reduction in the tone and motility of the gastro-intestinal tract leading
to constipation. Occasionally vomiting may occur.

SKIN: Rash erythematous and pruritis. Flushing and dryness of the skin, increased sweating.

OCULAR: Photophobia with or without corneal staining, significant increases in intraocular pressure, corneal
irritation, smarting eyes, severe oedema of the eyelids and rhinitis. Dilation of pupils (mydriasis) with loss of
accommodation (cycloplegia) and photophobia, risk of inducing angle closure where prior history, possibility of
elevating intra-ocular pressures.

Phenylephrine

Phenylepherine is an α adrenergic agonist. It contracts iris dilator muscle and the smooth muscle of
the conjunctival arterioles, causing blanching. Maximum dilatation is 45 to 60 minutes after instillation.
Recovery on average is 3 hours for 2.5% drops and 6 hours for 10% drops. Increased drug concentrations gives
more rapid onset but the maxium effect may still take up to 60 minutes [12].

Phenylephrine side effects and cautions

Local (ocular) effects; blurring, watering, photophobia, keratitis and rebound miosis (small pupil).
Systemic (whole body) effects; short term raised blood pressure, headache, increased heart rate (tachycardia)
and blanching of the skin.

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Contraindications to use of 10% phenylephrine; elderly patients with preexisting cardiac disease. Patient
taking mono-amine oxidase inhibitor (MAOIs) antidepressants, tricyclics or methyldopa. Side effects are more
likely with the higher concentrations.

Tropicamide and phenylephrine combination eye drops are widely used for mydriasis in routine
ophthalmoscopic examinations [1,3, 13]. and prior to cataract surgery to achieve maximal pupil dilation [4].
Phenylephrine hydrochloride, a sympathomimetic agonist, is a strong alpha1-receptor stimulant with little or
no beta-receptor effect. Cardiovascular actions of phenylephrine include vasoconstriction of the systemic,
pulmonary, and coronary arteries. Adverse systemic reactions have been reported following topical application
of 10% phenylephrine like elevated blood pressure, tachycardia, reflex bradycardia, cardiac arrhythmias
,
[12,14]. Tropicamide, on the other hand, is a parasympathomimetic antagonist that causes mydriasis and
cycloplegia [11]. It is devoid of vasopressor effect [11].

The RAF (Royal Air Force) Rule provides a binocular gauge to measure Objective and Subjective
Convergence as well as Accommodation in 1 mm increments. The RAF Rule consists of a 50 cm long rule with a
slider holding a rotating four-sided cube. Each side has a different target. The first has a vertical line with a
central dot for convergence fixation. The others provide a limited number of lines of near reading examples
[14].

A rest is provided for the cheek to insure consistency and proper height for the patient. Some studies
have shown greater consistence of the NPC when measured with the RAF Rule compared to using a pencil or
finger.

This instrument is used for determining the objective and subjective convergence points, examining
the accommodation and determining the master eye. The RAF Rule is useful for both diagnosis and treatment.

The instrument is made of metal and plastic; it is 50 cm. long and is marked on the top in centimetres,
and on the two sides in dioptres and the corresponding age groups.

On a metal slide is carried a quadrilateral which can be rotated to present on each of its four
washable white plastic faces the following optical tests:

(a) Reduced Snellen test type which subtends the same angle at the eye at 35 cm. as the test type subtends
at 6 metres.
(b) "Times Roman" type face recommended by the Faculty of Ophthalmologists (Law, 1951) presented in
four lines: N.5, N.8, N.O0, and N.12.
(c) Photographic reproduction of a section of the G.P.O. Telephone Directory.
(d) Vertical line and central dot for convergence fixation.

The new rule was made 50 cm. in length for two reasons:

(1) Many presbyopes with an indifferent power of convergence prefer to read at a distance of some 40 cm.
(2) The angle of 250 from the eye can be easily determined, by a point at the end of a rule 23-3 cm. long (tan
250 x 50) held at right angles to the end of the rod.

MATERIALS AND METHODS

• A Randomized controlled study comparing single(minimum 100 cases) versus multiple(minimum 100
cases) applications of combination of tropicamide and phenylephrine eye drops in patients attending
the Out Patient Department of Ophthalmology in Sri Siddhartha Medical College and Hospital,
Tumkur, between November 2011 to June 2013.
• After taking informed consent ,detailed history regarding patients name, age, sex, occupation,
address, presenting symptoms, duration, progression, were recorded. The patient was also enquired
about his past history, personal history and family history.
• Accommodation and convergence were assessed using Livingstone’s gauge/RAF rule.

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• The patients were randomly allocated into 2 groups, group A was administered single drop and group
B was administered multiple applications (at intervals of 10 minutes for a total of 40 minutes) of a
combination of 0.8% Tropicamide and 5% Phenylephrine.
• The pulse, blood pressure, pupil size, convergence and cycloplegia were assessed every 10 minutes
for a total duration of 40 minutes.
• The patients fundus was examined with a direct ophthalmoscope, and their retinoscopy values were
recorded using a streak retinoscope

OBSERVATION

The mean age of the participants in my study was 25.3 ± 2.83 years in the single application group and
24.83 ± 2.66 years in the multiple application group(range 20-40 years).48.5% were in the 20-24 years
category,44.5% in the 25-29 years category, 7% in the 30-34 years category and none in the 35-40 years
category with a mean age of 25.07 years(minimum of 20 years and maximum of 34 years).

Table 1: Age and sex distribution

Age Group Male Female Total

Number %
20 - 24 years 41 56 97 48.5
25 - 29 years 57 32 89 44.5
30 -34 years 7 7 14 7
105 (52.5%) 95 (47.5%) 200

The sex distribution in my study was 47.5% females and 52.5% males.

Table 2: The baseline data of all patients in both the groups.

Single Application Multiple Application

Number of Patients 100 (200 eyes) 100 (200 eyes)
Male / Female 52 / 48 53 / 47
Age, in years, Mean ± SD 25.3 ± 2.83 24.83 ± 2.66
Pupil size mean ± SD (in mm) 3.02 ± 0.14 3.04 ± 0.2
Pulse mean 70.80 ± 5.55 / min 71.58 ± 5.40 / min
Blood Pressure, mean systolic 118.66 ± 5.07 mm Hg 119.26 ± 2.75 mm Hg
Blood Pressure, mean Diastolic 76.24 ± 3.86 mm Hg 76.78 ± 4.36 mm Hg

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Table 3: The effect on NPA in each group at various time intervals.

NPA, mean ± SD (in cm) T – test

Single Application Multiple Application P – value
#
Baseline 12.13 ± 0.86 11.83 ± 1.02 0.025
10 mins 17.80 ± 1.72 17.33 ± 1.69 0.469*
#
20 mins 23.95 ± 2.29 23.16 ± 2.30 0.016
30 mins 29.74 ± 1.77 29.88 ± 2.51 0.649*
40 mins 34.35 ± 1.77 34.49 ± 1.53 0.550*
#
p-values are significant. * p-values are not significant.

Table 4: The effect on NPC in each group at various time intervals.

NPC, mean ± SD (in cm) T – test

Single Application Multiple Application P – value

Baseline 7.77 ± 1.32 7.63 ± 1.08 0.414*

10 mins 8.08 ± 1.44 7.95 ± 1.21 0.490*
20 mins 8.58 ± 1.64 8.34 ± 1.33 0.257*
30 mins 9.01 ± 1.72 8.87 ± 1.35 0.523*
40 mins 9.27 ± 1.98 9.05 ± 1.45 0.371*

* p-values are not significant.

Table 5: The effect on systolic blood pressure in each group at various time intervals.

Systolic Blood pressure, mean ± SD (mm Hg) T – test

Single Application Multiple Application P – value
Baseline 118.66 ± 5.07 119.26 ± 2.75 0.300*
10 mins 119.02 ± 5.04 119.94 ± 2.85 0.114*
20 mins 120.18 ± 5.27 121 ± 2.82 0.172*
30 mins 121.90 ± 8.57 122.18 ± 3.06 0.792*
40 mins 121.52 ± 5.4 122.56 ± 3.27 0.101*

Table 6: Adverse reaction in single and multiple group

Adverse Reaction No adverse reaction

Single drug group 0 100
Multiple drug group 0 100

DISCUSSION

The mean age of the participants in my study was 25.3 ± 2.83 years in the single application group and
24.83 ± 2.66 years in the multiple application group(range 20-40 years).48.5% were in the 20-24 years
category,44.5% in the 25-29 years category, 7% in the 30-34 years category and none in the 35-40 years
category with a mean age of 25.07 years (minimum of 20 years and maximum of 34 years).

The sex distribution in my study was 47.5% females and 52.5% males.

In this study, we compared the cycloplegia attained in an adult with Tropicamide phenylepherine
combination drops, in single drops versus multiple drops and evaluated for any systemic adverse reaction of
the drops.

The baseline near point of accommodation was significantly lower in the multiple group as compared
to the single group(12.13 ± 0.86 cm baseline near point of accommodation in single group; 11.83 ± 1.02 cm
baseline near point of accommodation in multiple group; p- value 0.025 was significant). The near point of
accommodation after 20 minutes was found to be also significantly lower in the multiple group as compared to
the single group(23.95 ± 2.29 cm after 20 minutes in single group; 23.16 ± 2.30 cm after 20 minutes in multiple
group; p-value 0.016 was significant). But the final near point of accommodation after 40 minutes in both the

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single and multiple applications groups were similar(34.35 ± 1.77 cm in single group; 34.49 ± 1.53 cm in
multiple group; p-value not significant).

The baseline near point of convergence, near point of convergence every 10 minutes and the near
point of convergence after 40 minutes in both the groups, the single application and the multiple application
groups was similar (7.77 ± 1.32 cm baseline in single group; 7.63 ± 1.08 cm in multiple group; p-value not
significant and 9.27 ± 1.98 cm after 40 minutes; 9.05 ± 1.45 cm after 40 minutes; p-value not significant).
Moreover the increase in the near point of convergence after 40 minutes was not significant in both the
groups.

The effect of the drug was studied on the near point of accommodation (cycloplegic effect) as well as
near point of convergence in both the groups. It was found that pupillary dilatation was associated with
cycloplegia in both the groups and the cycloplegic effect was comparable. However the increase in the near
point of convergence was not significant in both the groups.

Hamasaki I et al conducted a study to evaluate the cycloplegic effect of mixed eye drops containing
0.5% tropicamide and 0.5% phenylephrine in myopic children, and to determine whether their efficacy was
associated with their clinical characteristics. They found that the insignificant magnitude of residual
accommodation indicated that the mixed eye drop is an acceptable and useful cycloplegic agent in Japanese
schoolchildren with a wide range of myopic refractive errors [15].

Zhu X et al studied the effect of 0.5% Tropicamide/0.5% phenylepherine drops and made inter eye
refractive comparison in Chinese adults and concluded that accommodation was relaxed by the mixed drops in
myopic adults , the changes of refraction due to cycloplegia were not well correlated , probably due to ocular
dominance [16].

Manny R E et al studied the cycloplegic effect of Tropicamide 1% eyedrops in myopic children and its
variability compared to age, gender, iris colour ethnicity and magnitude of refractive error and concluded that
tropicamide is an effective cycloplegic agent in myopic children [17].

Egashira SM et al did a double masked study Comparing the Cycloplegic effect of tropicamide 1% and
cyclopentolate 1% in 20 non strabismic, non-Amblyopic, children aged 6-12 year and suggested that though
tropicamide is as effective cyclopentolate in inhibiting accommodation, it is nevertheless a useful cycloplegic
agent for, measuring the distance refractive error of low to moderate Hyperopia in school children [18].

In our study the baseline systolic blood pressure, systolic blood pressure every 10 minutes and the
systolic blood pressure after 40 minutes was similar in both the groups(118.66 ± 5.07 mm Hg baseline in single
group; 119.26 ± 2.75 mm Hg baseline in multiple group; p-value not significant and 121.52 ± 5.4 mm Hg after
40 minutes in single group; 122.56 ± 3.27 mm Hg after 40 minutes in multiple group; p-value was not
significant). The increase in the systolic blood pressure was not significant in both the groups.

Motta M et al compared the cardiovascular effects of phenylephrine 2.5% versus phenylephrine

10%. Their results corroborate the finding that one single drop of either 2.5 or 10% has no effect on blood
pressure and, when 1% tropicamide is combined, satisfactory pupil dilation is achieved [19].

In a study by Bhatia et al mild rise in systolic BP about 3 mm of Hg ( SD 19.03) and 1 mmHg in Diastolic
( SD 11.5) was seen, and hence they concluded though not much change is seen in normotensive patients, care
should be taken in using 10% phenylepherine in hypertensives [2].

Chin et al reported significant increase in BP after instilling 2.5% or 10% phenylepherine in

preoperative patient, However their study does not take into account the effect of anxiety and adrenalin
mixed in local anaesthetic [21].

SUMMARY

200 outpatients were randomised into 2 groups- a single application group of 100 patients and
multiple application group of 100 patients. Statistical analysis shows that cycloplegia in both the groups and

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the cycloplegic effect was comparable. However the increase in the near point of convergence was not
significant in both the groups. In this study, the effect of the combination drug of tropicamide and
phenylephrine on pulse and blood pressure(systolic and diastolic) was not found to be significant. Moreover,
no adverse drug reactions were noted in any of the study participants.

CONCLUSION

Thus we can conclude that Tropicamide phenylepherine combination drop can be an effective
cycloplegic in adults, whose accommodation reserve are weaker compared to children. The effect of
cycloplegia did don’t differ with the number of instillations. Also no systemic adverse effects were noted with
the drops.

Thus a single drop of combination of tropicamide and phenylephrine can be as efficacious as using
multiple drops of the same for routine pupillary dilatation for fundoscopic examination,for producing
cycloplegia as well as preoperatively before cataract surgery.

This can lowers the risk of adverse reactions which have been reported with the use of phenylephrine
and is thus safer ,as compared to multiple applications.

It also reduces the requirement of the man power required for Carrying out dialatation in the OPD.

Moreover this can significantly reduce the cost as well as the need for manpower for instillation of
drops.
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