Efficacy of probing accompanied by mitomycin-c for treatment of complete, primery nasolacrimal duct obstruction in adults in Jahrom Mottahari hospital between 1386-88
The objective of this study is to determine the efficacy of probing with adjunctive mitomycin-c (MMC) in adults with nasolacrimal duct obstruction (NLDO).This is a randomized, double-blind, placebo controlled trial study. The study population compromised adults with nasolacrimal duct obstruction. We will include men and women adult patients aged 18 or more with chief complaint of epiphora and will exclude those with lacrimal duct anomalies. Sample size will be 140 patients whom will divide into two groups (each one with 70 patients). Case group will receive 0.2 mg/ml mitomycin-c and controls will receive normal saline as placebo. Patients will be followed up 9 moths. Patients’ post probing epiphora was evaluated at 2 weeks, 1, 3, 6 and 9 months postoperatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040310241N1
Registration date:2013-04-11, 1392/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-11, 1392/01/22
Registrant information
Name
Mohamed Amin Ghobadifar
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1636 1386
Email address
m.ghobadi@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2009-12-03, 1388/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of probing accompanied by mitomycin-c for treatment of complete, primery nasolacrimal duct obstruction in adults in Jahrom Mottahari hospital between 1386-88
Public title
Efficacy of probing with mitomycin-c in treatment of nasolacrimal duct obstruction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1. Adults aged 18 or more.
2. Both sexes of men and women.
3. Patients with chief complaint of epiphora.
Exclusion criteria:
1. Eye trauma.
2. Nasal structure abnormalities.
3. lacrimal system tumors.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Jahrom University of Medical Sciences
Street address
Research department, Jahrom University of Medical Sciences, Motahari avenue, Jahrom, Fars, Iran
City
Jahrom
Postal code
193
Approval date
2007-07-31, 1386/05/09
Ethics committee reference number
5016/آ/د
Health conditions studied
1
Description of health condition studied
Nasolacrimal duct obstruction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of epiphora
Timepoint
Two weeks, 1, 3, 6, and 9 months post intervention.
Method of measurement
Observational
Secondary outcomes
empty
Intervention groups
1
Description
0.2 mg/ml mitomycin-c during nasolacrimal probing
Category
Treatment - Drugs
2
Description
Normal saline during nasolacrimal probing
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari hospital
Full name of responsible person
Street address
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Kavous Solhjou
Street address
Research department, Jahrom University of medical Scieces, Jahrom, Fars, Iran
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Morteza Pourahmad
Position
M.D.
Other areas of specialty/work
Street address
Research department, Jahrom University of medical Scieces, Jahrom, Fars, Iran
City
Jahrom
Postal code
Phone
+98 79 1334 0406
Fax
Email
mohammad_gh70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Nader Degani
Position
M.D.
Other areas of specialty/work
Street address
Department of ophtalmology, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Postal code
Phone
+98 79 1334 0406
Fax
Email
deganin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohamed Amin Ghobadifar
Position
Medical Student
Other areas of specialty/work
Street address
Department of Student Research Committee, Jahrom University of Medical Sciences, Motahari avenue, Jahrom, Iran
City
Jahrom
Postal code
Phone
+98 79 1334 0406
Fax
Email
amin_m505@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)