Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000688987
Ethics application status
Approved
Date submitted
27/06/2011
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alterations of the anterior lens capsule in vitrectomized eyes with silicone oil tamponade
Scientific title
The electron microscopic findings of the anterior lens capsule of 10 eyes in vitrectomized eyes with silicone oil tamponade and 10 eyes of control patients were investigated and surface irregularities and silicone oil droplets were detected on the posterior surface of the anterior lens capsule.
Secondary ID [1] 262576 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Previous vitreoretinal surgery with silicone oil instillation performed for the following retinal conditions: rhegmatogenous retinal detachment with proliferative vitreoretinopathy, and proliferative diabetic retinopathy with nonclearing vitreous hemorrhage associated with tractional retinal detachment. 268177 0
Condition category
Condition code
Surgery 268357 268357 0 0
Surgical techniques
Eye 268370 268370 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All eyes underwent core vitrectomy followed by removal of the posterior hyaloid membrane and vitreous traction. Retinal photocoagulation was performed in selected eyes via a laser. After vitrectomy, the fluid in the vitreous cavity was exchanged with 1,000-centistoke silicone oil in all cases. All injections were performed with the same silicone oil (PDMS(Registered Trademark)).
Patients who had on clinical examination a posterior subcapsular cataract formation secondary to intravitreal silicone oil injection were eligible for this study. There were also 10 patients with posterior subcapsular cataracts called the control group. All eyes were operated on for silicone oil removal and cataract extraction by phacoemulsification with intraocular lens implantation in the same operation. The mean silicone oil removing time was 4.4+/-1.1 months (3-6 months). Surgeries were performed by one surgeon under local anesthesia by retrobulbar injection. Upper and lower temporal conjunctival incision were performed. Lower temporal sclerotomy for the infusion cannula was carried out and the infusion cannula was inserted. The anterior chamber was irrigated with balanced salt solution to remove possible small silicone bubbles. The anterior chamber was filled with sodium hyaluronate 1.4 % (Healon GV(Registered Trademark)). An anterior capsulorhexis with a diameter of approximately 4.0 to 5.0 mm was created in the central region of the anterior lens capsule. Anterior capsule was removed and examined with the electron microscopy. Phacoemulsification was accomplished through clear corneal incision. An acrylic intraocular lens was implanted in the bag. Upper temporal sclerotomy for removal of silicone oil was performed. The infusion canula was then opened, and silicone oil was aspirated actively using a syringe. A central posterior capsulotomy was performed in required cases by vitrectomy probe. A fundus was evaluated with the wide field system with indentation of the periphery to ensure that the retina was attached and the silicone oil completely removed. Subsequently fluid-air exchange was performed. Average surgery time is 1.5 hours. This is a parallel case control study
Intervention code [1] 266840 0
Treatment: Other
Comparator / control treatment
The control group included 10 patients of cataract extraction and intraocular lens implantation with no history of systemic or other ocular disease.
Control group
Active

Outcomes
Primary outcome [1] 269048 0
investigate the electron microscopic findings of the anterior lens capsule in vitrectomized eyes with silicone oil tamponade
Timepoint [1] 269048 0
Cataract surgery time
Secondary outcome [1] 276875 0
none
Timepoint [1] 276875 0
none

Eligibility
Key inclusion criteria
This study included 10 eyes of 10 consecutive patients who had cataract surgery combined with silicone oil removal at our institution.
Minimum age
39 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who had coexisting ocular disease, severe retinal disease or inflammatory ocular disease were excluded from the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. During the capsulorhexis, the anterior lens capsule was removed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The anterior capsule analysis was performed immediately after surgery. The electron microscopic specialist had no information the patient’s condition.
Simple randomisation by using a randomisation table created by computer software was used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All eyes were operated on for silicone oil removal and cataract extraction by phacoemulsification with intraocular lens implantation in the same operation.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3677 0
Turkey
State/province [1] 3677 0
Ankara

Funding & Sponsors
Funding source category [1] 267311 0
Self funded/Unfunded
Name [1] 267311 0
none
Country [1] 267311 0
Turkey
Primary sponsor type
Hospital
Name
SB Ankara Ulucanlar Eye Education and Research Hospital
Address
Ulucanlar Cad. No:59 06230 Altindag/Ankara
Country
Turkey
Secondary sponsor category [1] 266375 0
None
Name [1] 266375 0
none
Address [1] 266375 0
none
Country [1] 266375 0
Turkey
Other collaborator category [1] 252076 0
None
Name [1] 252076 0
none
Address [1] 252076 0
none
Country [1] 252076 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269303 0
SB Ankara Ulucanlar Eye Education and Research Hospital
Ethics committee address [1] 269303 0
Ethics committee country [1] 269303 0
Turkey
Date submitted for ethics approval [1] 269303 0
18/12/2006
Approval date [1] 269303 0
25/12/2006
Ethics approval number [1] 269303 0
34312

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

Contacts
Principal investigator
Name 32799 0
Address 32799 0
Country 32799 0
Phone 32799 0
Fax 32799 0
Email 32799 0
Contact person for public queries
Name 16046 0
Mehmet CITIRIK
Address 16046 0
Fakulteler Mah. Yazgan Sk. No: 34/12 06590 Cebeci/ANKARA/TURKEY
Country 16046 0
Turkey
Phone 16046 0
00903123623222
Fax 16046 0
00903123124827
Email 16046 0
[email protected]
Contact person for scientific queries
Name 6974 0
Mehmet CITIRIK
Address 6974 0
Fakulteler Mah. Yazgan Sk. No: 34/12 06590 Cebeci/ANKARA/TURKEY
Country 6974 0
Turkey
Phone 6974 0
00903123623222
Fax 6974 0
00903123124827
Email 6974 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.