Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000089033
Ethics application status
Approved
Date submitted
20/01/2010
Date registered
27/01/2010
Date last updated
27/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
comparing the use of the patients own anterior capsule to the topical application of Mitomycin C to enhance success rate of glaucoma filtering surgery in patients undergoing simaltenous cataract and glaucoma surgery
Scientific title
Anterior lens capsule versus Mitomycin-C as an adjunct to Trabeculectomy in combined Phacotrabeculectomy in patients with glaucoma and cataract to enhance the results of filtering surgery
Secondary ID [1] 1315 0
none
Universal Trial Number (UTN)
U1111-1113-4297
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 256622 0
Cataract 256623 0
Condition category
Condition code
Eye 256791 256791 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two site Phacotrabeculectomy; one site is the phaco incision the other site is the trabeculectomy inision, and at the end of the surgery, the removed anterior lens capsule was placed under the scleral flap in Group I, and Mitomycin C in Group II is applied under the scleral flap intra operatively in order to reduce the fibrosis and thus enhancing success rate of filteration surgery. the surgical procedure is about one hour duration
Intervention code [1] 255874 0
Treatment: Drugs
Intervention code [2] 255906 0
Treatment: Surgery
Comparator / control treatment
Group II is the comparator in which they receive Mitomycin C (MMC) (an antimitotic drug). Mitomycin C (MMC) is applied topicaly during surgery under the scleral flap to reduce fibrosis of the filtering bleb. the appliction was done as following 5 sponges soaked with MMC 0.4% were applied, under the conjunctiva nasal, temporal as well as posterior to the intended filtration site, under and above the sclera flap. The sponges were left in place for 3 minutes and removed on a first in, first out order. The site of sponges was then irrigated with 50 ml of Ringers lactate from the irrigating bottle attached to the phaco machine.
Control group
Active

Outcomes
Primary outcome [1] 257658 0
Intra ocular pressur reduction IOP. this measured by the aplanation tonometer
Timepoint [1] 257658 0
one months after surgery
Secondary outcome [1] 262938 0
saftey. this is assesed by the clinical examination at the regular follow-up visits
Timepoint [1] 262938 0
one year after surgery

Eligibility
Key inclusion criteria
Galucoma not controlled by maximum tioical medications.
cataract
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients without cataract.
Controlled intra ocular pressure by topical medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
41
Accrual to date
Final
Recruitment outside Australia
Country [1] 2382 0
Egypt
State/province [1] 2382 0
cairo

Funding & Sponsors
Funding source category [1] 256234 0
Hospital
Name [1] 256234 0
Al Nour eye hospital
Country [1] 256234 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Emarah
Address
6 El-Hegaz St, Cairo, Egypt Post code 11341
Country
Egypt
Secondary sponsor category [1] 251676 0
Individual
Name [1] 251676 0
Mostafa EL-Helw
Address [1] 251676 0
52 manyal street, 11451,Cairo Egypt
Country [1] 251676 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258433 0
Al Nour eye hospital ethical committe
Ethics committee address [1] 258433 0
Ethics committee country [1] 258433 0
Egypt
Date submitted for ethics approval [1] 258433 0
Approval date [1] 258433 0
22/12/2007
Ethics approval number [1] 258433 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30655 0
Address 30655 0
Country 30655 0
Phone 30655 0
Fax 30655 0
Email 30655 0
Contact person for public queries
Name 13902 0
Ahmed M Emarah
Address 13902 0
6 El-Hegaz St, Cairo, Egypt Post code 11341
Country 13902 0
Egypt
Phone 13902 0
+202 2455 0300
Fax 13902 0
Email 13902 0
[email protected]
Contact person for scientific queries
Name 4830 0
Ahmed M Emarah
Address 4830 0
6 El-Hegaz St, Cairo, Egypt Post code 11341
Country 4830 0
Egypt
Phone 4830 0
+202 2455 0300
Fax 4830 0
Email 4830 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.