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STUDY PROTOCOL
Any and all information presented in this document shall be treated as confidential and shall remain the exclusive
property of sreedhareeyam ayurvedic eye hospital. The use of such confidential information must be restricted to the
recipient for the agreed purpose and must not be disclosed, published or otherwise communicated to any unauthorized
persons, for any reason, in any form whatsoever without the prior
written consent of sreedhareeyam ayurvedic eye hospital .
Investigator Dr.N.P.P.Namboothri
President, Sreedhareeyam Ayurvedic Eye Hospital and
Research Institute,
Nelliakkattu Mana, Kizhakombu,
Koothattukulam,Ernakulam,
Kerala- 686662
Sponsor Ayush
Other Emergency
Telephone Numbers
Study Duration 1 year from baseline visit of the patient (per patient)
Study Population 50 patients; the number of patients can be increased as per need.
Assessment Schedule - Patient assessed at baseline visit will be enrolled for the trial if found eligible,
- There will be 2 inpatient treatment visits and telephonic follow ups will be
done every 3 months..
- Patients who discontinued study will be assessed for follow up in
every 3 months, at least up to their planned end of treatment period.
-End treatment will be 1 year from baseline visit +/-1months.
Statistical consideration The statistical analysis will be done with SPSS 15.0,ANOVA
Inclusion criteria ▪ Male and female; age- between 3-25yrs irrespective of sex, race, religion,
socio-economic status
▪ Patients clinically diagnosed as progressive myopia.
▪ Women of child bearing potential are required to have a documented
negative serum or urine pregnancy test before the start of therapy.
Exclusion criteria ▪ Patients with any eye associated complications.
▪ Advanced degenerative changes on opthalmoscopy.
▪ Any previous eyes operation.
▪ Any major disease associated
2. TABLE OF CONTENTS
1 FLOW CHARTS (VISITS AND STUDY PROCEDURES)....................................................................4
3 INTRODUCTION ………………..............................................................................................................6
7SELECTION OF PATIENTS.....................................................................................................................9
7.1 NUMBER OF PATIENTS PLANNED.....................................................................................................9
7.2 INCLUSION CRITERIA...........................................................................................................................9
7.3 EXCLUSION CRITERIA .........................................................................................................................9
7.4 ASSESSMENT PARAMETERS………………………………………………………………………...9
8TREATMENTS…......................................................................................................................................10
9PATIENT SAFETY....................................................................................................................................11
9.1 ADVERSE EVENTS MONITORING.....................................................................................................11
9.2 DEFINITIONS OF ADVERSE EVENT(AE)………………………………………………………..…11
13 STATISTICAL CONSIDERATIONS.................................................................................................12
15 STUDY MONITORING.........................................................................................................................13
15.1SOURCE DOCUMENT REQUIREMENTS..........................................................................................13
15.2USE AND COMPLETION OF CASE REPORT FORMS AND ADDITIONAL REQUEST. ............13
17 CONFIDENTIALITY.............................................................................................................................14
18 DATA PROTECTION............................................................................................................................14
3. INTRODUCTION:
The refractive changes appears in early childhood, usually between 5-10 yrs & increases
steadily upto 25 yrs or beyond resulting in a high degree of myopia, accompanied by
degenerative changes in choroids & other parts of eyes.
The key findings associated with progressive myopia can be seen on ophthalmoscopic
examination of the posterior pole: myopic crescent; posterior staphyloma; flat, obliquely
inserted discs; patchy choroidal atrophy. Extensive vitreous syneresis and posterior
vitreous detachment are typical. Additional findings include lacquer cracks’ sub retinal
neovascular membrane, fuch’s spot, retinal breaks and retinal detachment.
According to Ayurveda the visible areas of eye include five mandalas,six
sandhis and six patalas.By our ancient Aacharyas 76 eye disease are mentioned in
texts.Out of them few are refractive errors which are common in today’s life. Although
these refractive errors are very common but they affects one’s life significantly.
Progressive myopia in modern science has no definite terminology in classical Ayurveda.
But some drishtigataroga lakshnas have symptomatic similarity with Progressive myopia.
A deeper study and classification of pratham & dwitiya patalgata Timira in dristigata
rogas can be done on the basis of several stages of samprapthi in dristipatalas.
There has not been proposed any specific line of treatment in modern
management, other than spectacular correction or laser management, so it is worth to
discuss the Ayurvedic perspective in the therapeutics of Progressive myopia.
Vitiated kapha dosha progresses towards 2nd ( Mamsa dhatu) patala of eye
this is a milestone in pathogenesis of the disease ,when doshas get localized (sthana
samshrayam) in 2nd patala ( mamsa ashritapatala) and srotorodhana reaches at its peak.As
a result vata dosha also gets affected & degenerative process comes in picture. Due to
these changes vision gets more blurrd , patient sees non-existing thingse.g. haiors,spider
webs ect and sees distant things near and near things far away. If doshas are accumulated
in the upper part of the patala then perception of distant objects will be difficult.This
stage is more prone to vata dosha drusthi, more potent vata shaman & shodana drugs
should be given for a longer duration.
SYMPTOMS:
• Defective Vision.
• Floating black opacities in front of the eyes, occur due to degenerated liquefied
vitreous.
• Night Blindness (by very high myopes having marked degenerative changes)
• Headaches
• Sensitivity to light
SIGNS:
• The eyes are often prominent, appearing elongated & even simulating an
exophthalmos especially in unilateral cases mainly affecting the posterior pole &
surrounding area.
• Cornea is large& Pupils are slightly large, reacts sluggishly to light.
FUNDUS EXAMINATION:
4. STUDY OBJECTIVE:
5. STUDY DESIGN:
5.1 DESCRIPTION OF THE PROTOCOL
SAR-PM is an observational trial. Patients who meet inclusion criteria, and who do not
meet exclusion criteria will be randomized in this trial.
The individual treatment duration will be variable, depending on the total duration of the
study. The minimum inpatient treatment duration for each patient will be 21 days. There
will be two inpatient visit each consisting of 21 days during the protocol period. All
patients will visit the clinic once every six months for clinical assessment and for
assessment of treatment compliance. In addition, telephonic follow-ups will be done in
every 3 months after randomization of the patient.
During the course of the trial, an Independent Data Monitoring Committee (DMC) will
Periodically review safety.
The study end-date will be 12 months following randomization of the last patient. All
patients must be followed up to the planned end of treatment period
7. SELECTION OF PATIENTS
▪ Male and female; age- between 3-25yrs irrespective of sex, race, religion,
socio-economic status
▪ Patients clinically diagnosed as progressive myopia.
▪ Women of child bearing potential were required to have a documented negative serum
or urine pregnancy test before the start of therapy.
I. Efficacy:
1. Auto refraction is used for the assessment of refractive status of each eye.
2. Eye examination by ophthalmologist / doctors.
3. Visual acuity as assessed by Snellen’s chart at every visit of the patient for 1 year
before and after the treatment
4. National eye institute refractive error quality of life instrument-42(NEI RQL-42)- to
improve the knowledge about vision correction and how it affects the personal life of
a person.
- Defective Vision
- Headaches
- Watering of eyes
- Sensitivity to light
- Floating black opacities in front of the eyes
- Night Blindness
III. Signs assessed will be:
The symptoms will be assessed by means of a linear scale from 0-3 where:
0 = symptoms absent.
1 = mildly affected by the symptoms.
2 = moderately affected by the symptoms
3 = severely affected by the symptoms
The minim score will be 0 and maximum will be 30
8. TREATMENTS
After the patient is randomized and is the inpatient following treatment will be done
according to the patients complaints:-
Nasayam : - Anutailam
- Ksheerabala 21 Av
Sekam : - Kashyapasekam
Aschotanam : - Ananthagritham
Sirodhara : - Sasankathailam
- Balaswagandha thailam
- B P thailam
Pichu : - Sasankathailam
- Balaswagandha thailam
- B P thailam
Internal medication may vary according to the physician and will be noted.
9. SAFETY INSTRUCTIONS
9.1 ADVERSE EVENTS MONITORING
All events will be managed and reported in compliance with all applicable regulations,
and included in the final clinical study report.
10.1 CONSEQUENCE
Patients who have withdrawn from the study cannot be re-included in the study. Their
inclusion and treatment number must not be reused.
I At Baseline: The screening and baseline visit will be on the same day with the
refraction test done on same day or +1 day.
Quality of life questionnaire will be assessed by self-reporting
IV Assessments at Visit 2(6 months from the baseline visit +/- 1 month): Auto
refraction, eye examination, visual acuity, Quality of life questionnaire will be
assessed.
The statistical analysis will be done with SPSS 15.0 & ANOVA.The changes in
refraction and visual acuity will be assessed from baseline to end of study, paired t-test.
ANOVA provides a statistical test of whether or not the means of several groups are all
equal.
to the respective other party a copy of the written and dated approval/favorable opinion
signed by the Chairman with Ethics Committee (IRB/IEC) composition.
During the Clinical Trial, any amendment or modification to the Clinical Trial Protocol
should be submitted to the Ethics Committee (IRB/IEC) before implementation, unless
the change is necessary to eliminate an immediate hazard to the patients, in which case
the IRB/IEC should be informed as soon as possible. It should also be informed of any
event likely to affect the safety of patients or the continued conduct of the Clinical Trial,
in particular any change in safety.
A progress report is sent to the Ethics Committee (IRB/IEC) at least annually and a
summary of the Clinical Trial’s outcome at the end of the Clinical Trial.
15.2 USE AND COMPLETION OF CASE REPORT FORMS (CRFS) AND ADDITIONAL
REQUEST
It is the responsibility of the Investigator to maintain adequate and accurate CRFs
designed by the Sponsor to record all observations and other data pertinent to the clinical
investigation. All CRFs should be completed in their entirety in a neat, legible manner to
ensure accurate interpretation of data.
Should a correction be made, the information to be modified must not be overwritten.
The corrected information will be transcribed by the authorized person next to the
previous value, initialed and dated.
17. CONFIDENTIALITY
Protocol, the CRFs, and the results obtained during the course of the Clinical Trial, is
confidential.
However, the submission of this Clinical Trial Protocol and other necessary
documentation to the Ethics Committee (IRB/IEC) is expressly permitted, the IRB/IEC
members having the same obligation of confidentiality.