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Trial registered on ANZCTR


Registration number
ACTRN12610000914066
Ethics application status
Approved
Date submitted
25/10/2010
Date registered
26/10/2010
Date last updated
26/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rigid iris-fixated phakic lens implantation for high myopia: Novel trapezoidal corneal versus scleral incisions
Scientific title
Comparison of refractive performance of implantation of an iris-fixated phakic intraocular lens (PIOL) through a novel trapezoidal corneal and a scleral tunnel incision.
Secondary ID [1] 252945 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High myopia 258477 0
Condition category
Condition code
Eye 258642 258642 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phakic iris-fixated intraocular lens implantation for high myopia through a novel self-sealing corneal incision.
The procedure can be finished in 5-10min and performed once only each subject.
Intervention code [1] 257473 0
Treatment: Surgery
Comparator / control treatment
Phakic iris-fixated intraocular lens implantation for high myopia through a traditional scleral tunnel incision.
The procedure can be finished in 15-20min and performed once only each subject.
Control group
Active

Outcomes
Primary outcome [1] 259497 0
All the corneal incision eyes had clear cornea and two eyes in scleral incision group(5.71%) had mild to moderate corneal edema that resolved within one week
Timepoint [1] 259497 0
One day after surgery
Primary outcome [2] 259499 0
The percent of eyes with Best corrected visual acuity(BCVA )of >20/25 was 82.4% (28/34) for corneal group and 80.0% (28/35) for scleral group (P=0.80). No eye lost 1or more lines of BCVA in both groups
Timepoint [2] 259499 0
Three and six months after surgery
Primary outcome [3] 259500 0
The mean corneal astigmatism was less in corneal group than scleral group
Timepoint [3] 259500 0
Three and six months after surgery
Secondary outcome [1] 266088 0
There were no significant postoperative differences between groups in mean intraocular pressure and endothelial cell density.
Timepoint [1] 266088 0
Three months after surgery
Secondary outcome [2] 266089 0
There were no significant postoperative differences between groups in mean intraocular pressure and endothelial cell density.
Timepoint [2] 266089 0
Six months after surgery

Eligibility
Key inclusion criteria
(1) anterior chamber depth (ACD) of 3.0 mm or greater with regular iris configuration; (2) preoperative endothelial cell count of 2000 cells/mm2 or greater; (3) preoperative spherical equivalent (SE) greater than -15.0 D, with astigmatism less than 2.0 D; (4) stable refraction, defined as less than 0.5 D change for more than 1 year; (5) no other ocular and systemic diseases.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) abnormal iris, cornea, pupil, or retina; (2) acute inflammation; (3) any form of cataract; (4) glaucoma; (5) chronic or recurrent uveitis; (6) preexisting macular degeneration, retinopathy, or family history of retinal detachment; (7) intraocular pressure (IOP) higher than 21mm Hg; (8) chronic treatment with corticosteroids or any immunosuppressive treatment or state.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2989 0
China
State/province [1] 2989 0

Funding & Sponsors
Funding source category [1] 257925 0
Hospital
Name [1] 257925 0
Beijing Tongren Hospital, Capital Medical University
Address [1] 257925 0
1 dong jiao min xiao, Beijing,100730
Country [1] 257925 0
China
Primary sponsor type
Hospital
Name
Beijing Tongren Hospital, Capital Medical University
Address
1 dong jiao min xiao, Beijing,100730
Country
China
Secondary sponsor category [1] 257116 0
None
Name [1] 257116 0
Address [1] 257116 0
Country [1] 257116 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Implantation of rigid iris-fixated phakic intraocular lens (PIOL) is considered as a promising alternative for high myopia. However, a conventional large sclerocorneal or scleral incision is commonly needed for this PIOL implantation because of the polymethylmethacrylate material. Thus, it involves much ocular tissue manipulation and surgical time, which should induce the postoperative astigmatisms and affect the rapid postoperative visual recovery. Although the foldable version of lens has been created recently, it is a rather new technique and long-term evaluation is not available. Therefore, the rigid PIOL is still a widely accepted and frequently used means for high myopia, especially in developing countries. Therefore, we present a novel surgical technique that is specially designed for rigid PIOL implantation and compare it with conventional scleral incision. This study aimed to compare the postoperative visual outcomes of these two incisions for the surgical correction of high myopia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31826 0
Address 31826 0
Country 31826 0
Phone 31826 0
Fax 31826 0
Email 31826 0
Contact person for public queries
Name 15073 0
Siquan Zhu
Address 15073 0
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Lab.
1 Dong Jiao Min Xiang, Beiing100730, China.
Country 15073 0
China
Phone 15073 0
861058269605
Fax 15073 0
Email 15073 0
wkj_2801@163.com
Contact person for scientific queries
Name 6001 0
Siquan Zhu
Address 6001 0
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Lab.
1 Dong Jiao Min Xiang, Beiing100730, China.
Country 6001 0
China
Phone 6001 0
861058269605
Fax 6001 0
Email 6001 0
wkj_2801@163.com

No information has been provided regarding IPD availability
Summary results
No Results