Evaluating the effect of hyperopic orthokeratology contact lenses on near vision, refraction, topography and corneal thickness for correcting the presbyopia using monovision technique in non dominant eye
To evaluate the effect of hyperopic orthokeratology lenses based on Monovision technique in correction of presbyopia
Design
Non randomized sampling was performed.
The non-dominant eye was assigned to the intervention group and the dominant eye to the control group.The technique which was used for intervention was monovision.
Settings and conduct
After completing informed consent form, primary examination was conducted in optometry clinic and Mashhad Razavi hospital. Then hyperopic orthokeratology lenses were ordered and non-dominant eyes were fitted with these lenses.
Following from this, flurescein pattern were evaluated and after that, participants were asked to wear contact lenses for 7 nights (at least 6 hours per night). Participants were followed for one week and ocular examination was done at first and seventh day after wearing lenses
Participants/Inclusion and exclusion criteria
Inclusion criteria: emmetropic persons with blurred near vision; age range of 43-50 years old; completing informed consent form; uncorrected distance visual acuity at least 6/9.
Exclusion criteria: Against the rule astigmatism; any kind of ocular and systemic disease; ocular surgery history,; previous history of wearing RGP or hard contact lenses; with the rule astigmatism more than 1.5 diopter
Intervention groups
Intervention group:non dominant eye. Control group:dominant eye.
Non dominant eye is fitted with orthokeratology contact lenses.This study included a total of 11 participants that right eye and left eye were non-dominant in 2 and 9 patients,respectively. Dominant eye was considered as a control group (without intervention).
Main outcome variables
Changes in near visual acuity; central axial curvature; peripheral axial curvature and central corneal thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200228046640N1
Registration date:2020-04-27, 1399/02/08
Registration timing:retrospective
Last update:2020-04-27, 1399/02/08
Update count:0
Registration date
2020-04-27, 1399/02/08
Registrant information
Name
nasrin mohammadpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3620 1371
Email address
opto_nmp@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-13, 1398/01/24
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-04-13, 1398/01/24
Actual recruitment end date
2019-09-19, 1398/06/28
Trial completion date
2019-12-21, 1398/09/30
Scientific title
Evaluating the effect of hyperopic orthokeratology contact lenses on near vision, refraction, topography and corneal thickness for correcting the presbyopia using monovision technique in non dominant eye
Public title
The effect of orthokeratology night time contact lenses for correcting presbyopia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Emeteropic persons age range of 43-50 years
Unaided distance visual acuity in dominant eye at least 6/9
Blurred near vision
Exclusion criteria:
The amount of with the rule astigmatism more than 1.5 diopter
Presence of against the rule astigmatisem
eye disease
systemic disease
ocular surgery history
History of wearing RGP or hard contact lenses
Age
From 43 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
11
Actual sample size reached:
11
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National ethics committee in biomedical research, Mashhad University of Medical Sciences
Street address
Optometry group, paramedical college, university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.MUMS.REC.1397.310
Health conditions studied
1
Description of health condition studied
Presbyopia
ICD-10 code
H52.4
ICD-10 code description
Presbyopia
Primary outcomes
1
Description
Near visual acuity
Timepoint
Before intervention, one day and 7 days after intervention
Method of measurement
Visual acuity chart
2
Description
Central axial curvature
Timepoint
Before intervention, one day and 7 days after intervention
Method of measurement
Topography
3
Description
Peripheral axial curvature
Timepoint
Before intervention, one day and 7 days after intervention
Method of measurement
Topography
Secondary outcomes
1
Description
Refraction
Timepoint
Before intervention, one day and 7 days after intervention
Method of measurement
Auto reFractometer
Intervention groups
1
Description
Intervention group :non-dominant eye .This is a "contralateral eye study" that non-dominant eye is fitted with hyperopic orthokeratology Boston xo contact lenses. This study included a total of 11 participants that right eye and left eye were non-dominant in 2 and 9 patients,respectively.
Category
Treatment - Devices
2
Description
Control group: Dominant eye was conducted as a control group with out any intervention.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of optometry
Full name of responsible person
Nasrin Mohammadpanah
Street address
Optometry department; Paramedical School; university campus; Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Fax
+98 51 3884 6728
Email
sps.Dean@MUMS.AC.IR
Web page address
https://optometrydept.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Ostadi Moghadam
Street address
Paramedical School; university campus; Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Fax
+98 51 3884 6728
Email
sps.Dean@mums.ac.ir
Web page address
https://optometrydept.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?