Clinical trial comparing the effects of Tea Tree Oil and artificial tear and betamethasone drops on dry eye symptoms after phacoemulsification cataract surgery
This study is a clinical trial and be carried on in Farabi Ophthalmology Center that examine the dry-eye symptoms following a Phacoemulsification Cataract Surgery. The volunteers fill the Ocular Surface Disease questionnaire, and they are selected if: (1) Dry-eye symptoms following Phacoemulsification Cataract Surgery that have not improved after 1 month with conventional treatments(2) The questionnaire index is equal or more than 30. The patients are excluded if they have historic eye surgeries or diseases that cause dry eye. We will record all the relevant information from the acuity vision and Tear osmolarity testing and microscopic demodex examinations. In this study we investigate 60 eyes of 60 patients. The selected volunteers are randomly divided in two groups: (A) trial and (B) control. The control group takes Artificial Tear and betamethasone 0.1% drop and eyelid washing with eyesol shampoo without TTO every 8 hours a day for one month and the trial group takes Artificial Tear and betamethasone drop in the same way as control group as well as eyesol shampoo with TTO 5%. After one months, we repeat all the above-mentioned tests and Ocular Surface Disease Index Questionnaire. We will then compare the results of these two groups. The main outcome of this study is to compare the effects of Tea Tree Oil and artificial tear and betamethasone drops on dry eye symptoms after surgery, cataract Phacoemulsification method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111313567N5
Registration date:2015-06-21, 1394/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-21, 1394/03/31
Registrant information
Name
Mehrdad Mohammadpour
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 6286
Email address
mohammadpour_m@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-06-15, 1394/03/25
Expected recruitment end date
2015-08-16, 1394/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of Tea Tree Oil and artificial tear and betamethasone drops on dry eye symptoms after phacoemulsification cataract surgery
Public title
Impact of Tea Tree Oil on dry eye treatment
Purpose
Treatment
Inclusion/Exclusion criteria
The Inclusion criteria: Dry-eye symptoms following Phacoemulsification Cataract Surgery that have not improved after 1 month with conventional treatments(artificial tear and betamethasone 0.1% drops); Index of 30 or more from the Ocular Surface Disease Questionnaire; The Schirmer test of 10 millimeter or less; The Tear Break up Times of 7 seconds or less; Lack of eye trauma; The absence of uveitis.
Exclusion criteria: Surgery on eyes including Surgical Correction of Refractive Errors; Using contact lenses; Systemic diseases which cause dry eye such as Sjogren ,Diabetic Retinopathy and end organ damage disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Organization of University, Qods Ave., Keshavarz Blvd., Valiasr Squ.Tehran .Iran
City
Tehran
Postal code
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
93-04-30-27770-148038
Health conditions studied
1
Description of health condition studied
Dry eye syndrome
ICD-10 code
H04.1
ICD-10 code description
Other disorders of lacrimal gland
Primary outcomes
1
Description
Moisture eye
Timepoint
Before intervention-one month after treatment
Method of measurement
Schirmer Test -Millimeters
2
Description
Eye problems in performing daily
Timepoint
Before intervention-one month after treatment
Method of measurement
Ocular Surface Disease Index Questionnaire
3
Description
Tear break up time
Timepoint
Before intervention-one month after treatment
Method of measurement
Measured in seconds -With timer and Slit Lamp
4
Description
Visual acuity
Timepoint
Before intervention-one month after treatment
Method of measurement
Snelen chart
5
Description
The number of demodex of 4 eyelashes of each eye
Timepoint
Before intervention-one month after treatment
Method of measurement
Microscopic demodex examination
6
Description
Tear Osmolarity
Timepoint
Before intervention-one month after treatment
Method of measurement
Tearlab osmometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first patient with a unique code (1) be given package A (i.e.Eyesol Ophthalmic cleansing shampoo containing Tea tree oil 5% plus Betamethasone Eye Drops 0.1% plus Artelac Eye Drops). Patients need to instil a drop of artificial Eye Drops, with trademark of Artelac, every 6 hours a day for one month. It contains 1.6 milligram (0.5 millilitre ) of artificial tears mainly hypromellose. In addition participants in the intervention group should instil a drop of Betamethasone Eye Drops 0.1% in the first week every 6 hours, the second week every 8 hours, the third week every 12 hours and the fourth week every 24 hours a day for one month. Betamethasone Eye Drops 0.1% with trademark of Betasonate is a product of Sina Darou. In addition participants in this group should scrub their eyelids every 8 hours with Eyesol Ophthalmic cleansing shampoo containing Tea tree oil 5%, Rewopol,Rewoteric ,HEC,PEG - 40 Hydrogenated castor oil produced in samin sirjan Co. under cooperative agreement with Dr. Straetmans Co. Germany. Volunteers continue this treatment for one month and return for examination afterwards.
Category
Treatment - Drugs
2
Description
Control group: The second patient with a unique code (2) be given package B (i.e.Eyesol Ophthalmic cleansing shampoo without Tea tree oil plus Betamethasone Eye Drops 0.1% plus Artelac Eye Drops). Patients need to instil a drop of artificial Eye Drops, with trademark of Artelac, every 6 hours a day for one month. It contains 1.6 milligram (0.5 millilitre ) of artificial tears mainly hypromellose. In addition participants in the control group should instil a drop of Betamethasone Eye Drops 0.1% in the first week every 6 hours, the second week every 8 hours, the third week every 12 hours and the fourth week every 24 hours a day for one month. Betamethasone Eye Drops 0.1% with trademark of Betasonate is a product of Sina Darou. In addition participants in this group should scrub their eyelids every 8 hours with Eyesol Ophthalmic cleansing shampoo (without Tea tree oil) containing Rewopol,Rewoteric ,HEC,PEG - 40 Hydrogenated castor oil produced in samin sirjan Co. under cooperative agreement with Dr. Straetmans Co. Germany. Volunteers continue this treatment for one months and return for examination afterwards.