INTRODUCTION

Eyes are the most precious gift of the living being. The human eye is the organ which gives us the sense of sight, allowing us to learn more about the surrounding world than we do with any other sense organ. When eyes lose their function, it leads to serious disability in man by keeping him in darkness, as life without eyesight is miserable and valueless. Hence, it is very important to protect vision from various serious diseases.

In Ayurveda, Drishtigata rogas have been explained by Acharya Sushruta in Uttartantra. Drishtigata rogas highlight about all the eye disorders leading to visual disturbances.  Timira, a drishtigata roga, is said to be “Param Darun Vyadhi[i]” which leads to progressive loss of vision. Timira has been described in terms of involvement of successive Patalas i.e layers of eye and the prognosis of the disease depends upon the involvement of respective Patala. Hence, Patalas have been described by Ancient Acharyas in order to show the severity of the diseases as they involve the deeper tissues of the eye. Timira is a disease in which there is gradual deterioration of vision and as well as other visual symptoms. It has three stages, namely timira (first and second patala affection), kacha (three patala affection) & lingnasha (four patala affected) [ii].

 â€œPresbyopia occurs when the physiologically normal age-related reduction in the eye’s focusing range reaches a point, when optimally corrected for distance vision, the clarity of vision at near is insufficient to satisfy an individual’s requirements[iii]”. People who become presbyopic may complain of headache and eye strain and hold objects progressively further away from their eyes in order to be able to focus on them.

NEED OF THE STUDY

Presbyopia is a common age-related eye disorder characterized by progressive loss of vision. Nearly 80% of people aged 35 years or above likely develop presbyopia. It is estimated that there were 1.8 billion people affected worldwide in 2015 and it is predicted that 1.9 billion people will be affected by 2050[iv]^.

In contemporary medical science treatment of presbyopia is prescription of appropriate convex glasses, contect lenses, refractive surgery or getting lens implants. These treatment modalities have their own limitations as they are not cost effective and provide only temporary relief to the patient. To provide a permanent solution to this an alternative approach is needed.

Therefore,this study has been planned to come out with safe and effective therapy in Ayurveda for the management of timira with special reference to Presbyopia.

AIM:

1.      To Compare the efficacy of Jeevantyadi Ghrita Aschyotana and Jeevantyadi Ghrita oral intake in the management of Timira with special reference to Presbyopia.

OBJECTIVES:

The present research work has been undertaken with the following main objectives-

1.     Clinical evaluation of the efficacy of Ashchyotana with Jeevantyadi ghrita in the management of Timira (Presbyopia).

2.     Clinical evaluation of the efficacy of Jeevantyadi ghrita oral intake in the management of Timira (Presbyopia).

PRIMARY OUTCOME:

     Change in amplitude of accommodation.

SECONDARY OUTCOME:

1.     The changes in asthenopic symptoms of presbyopic patients.

2.     To observe for any adverse effects of topical and systemic application of Jeevantyadi Ghrita in presbyopic patients.

MATERIALS AND METHODS:

The study has been divided in following sections.

·       Conceptual Study

·       Clinical Study

A) Conceptual study: There will be in review of relevant literature from Ayurvedic classics, modern medical science, Journals, Previous researches and internet in great depth for conceptualization of etio-pathogenesis of Presbyopia and probable mode of action of Ayurveda drugs.

B) Clinical study: 

            The study will be conducted under a strict protocol to prevent bias and to reduce the source of error in the study.

Source of data:

Patients – Patients attending the O.P.D. and I.P.D. of Shalakya Department of National Institute of Ayurveda, Jaipur will be screened out for the present study.

            Age Group – Patients above the age of 35 years of age will be selected for the study.

Criteria for selection of patients: Patients attending the O.P.D. and I.P.D. of N.I.A. will be screened having the signs and symptoms of prathama and dwitiya patalagata timira and Presbyopia. The diagnosis will be achieved on the basis of careful history taking and clinical examination.

Inclusion Criteria: 

      i.         Patients who are 35 -60 years of age and from either sex.

     ii.         Patients having specific symptoms of prathama and dwitiya patalagata timira.

   iii.         Presbyopia determined by screening monocular best-corrected distant visual acuity (VA).

Exclusion Criteria:

      i.         Patients with active ocular infection at visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (eg, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis), moderate to severe dry eye in either eye.

    ii.         Patients with clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of media opacity in either eye Patients having intraocular pressure (IOP) that is less than 5 millimeters of mercury (mmHg) or greater than 22 mmHg in either eye documented at visit 1, or have a prior diagnosis of ocular   hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication at visit

   iii.         Patients who have abnormal findings on dilated fundus examination in either eye on visit 1 or a known history of retinal detachment or clinically significant retinal disease in either eye.

   iv.         Patients with known history or diagnosis in the past of: iritis, scleritis or uveitis, whether active or inactive.

     v.         Patients who have had surgical intervention (ocular or systemic) within 6 months prior to visit.

   vi.         Patients with severe systemic illnesses.

  vii.         Planned intra ocular or extra ocular surgery in either eye during study period.

STUDY DESIGN:

HYPOTHESIS:

Null hypothesis: Jeevantyadi ghrita Ashchyotana and Jeevantyadi ghrita oral intake have no effect on prathama and dwitiya patalagata timira with special reference to presbyopia.

Alternate hypothesis: Jeevantyadi ghrita Ashchyotana and Jeevantyadi ghrita oral intake have effect on prathama and dwitiya patalagata timira with special reference to presbyopia.

Type of study:  Clinical study

Study design: Randomized prospective parallel group trial

Masking/Blinding: Open label

Timing: Prospective

Method of Randomization: Computer generated Random Sequence

No of groups: 2

Sample size: 15 patients in each group, total 30 patients.

Grouping: In the present study 30 clinically diagnosed patients of prathama and dwitiya patalagata timira (Presbyopia) will be selected and randomly divided into two groups:

Group I: 15 patients of prathama and dwitiya patalagata timira (Presbyopia) will be administered Ashchyotana with Jeevantyadi ghrita 3 drops 4 times a day.

Group II: 15 patients of prathama and dwitiya patalagata timira (Presbyopia) will be administered   Jeevantyadi ghrita 10ml with godugdha oral intake once a day at bedtime.

Drug, dose and duration of trial:

Group A:         Ashchyotana with Jeevantyadi ghrita 3 drops 4 times a day[v].

Group B:         Jeevantyadi ghrita 10ml with godugdha oral intake once a day at bedtime.

Duration: 30 Days

Follow Up: 32 days!

Assessment criteria: For assessment of the efficacy of the trial, following criteria will be adopted-

The symptoms and signs of prathama and dwitiya patalagata timira (with special reference to Presbyopia) will be assessed before and after the trial. The symptoms are -

1.      Suchipasham na pashyati (Difficulty in near vision), photophobia.

2.     Avyakta Darshana (Samipastha and Durastha)

3.     Vihwala Darshana

4.     Netrayasa (Eye strain)

5.     Shirobhitapa (Headache)

6.     Netrasrava (Watering)

7.     Visual Acuity and logMAR

8.     Amplitude of Accomodation

9.     K1 and K2 Values (Autokeratometry)

10.  Central corneal thickness (NCT)

11.  Axial length (A scan)

12.  IOP (NCT)

13.  Central macular cube thickness (OCT)

Investigations:

-       CBC, ESR

-       Blood sugar fasting

-       Lipid profile, Liver function tests