| CTRI Number |
CTRI/2010/091/000195 [Registered on: 15/03/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the comparison of hydrophilic intraocular lens and silicone lens in children undergoing cataract surgery |
|
Scientific Title of Study
|
Comparitive study of visual performance following implantation of square edge hydrophobic acrylic and silicone intraocular lenses in pediatric cataract |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MS/330/MS/6233 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma Bhusal |
| Designation |
|
| Affiliation |
|
| Address |
Advanced Eye centre
Sec 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756111 |
| Fax |
|
| Email |
drsushmabhusal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jagat Ram |
| Designation |
|
| Affiliation |
|
| Address |
Advanced Eye centre
Sec 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756111 |
| Fax |
|
| Email |
drjagatram@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jagat Ram |
| Designation |
|
| Affiliation |
|
| Address |
Advanced Eye centre
Sec 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756111 |
| Fax |
|
| Email |
drjagatram@yahoo.com |
|
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Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research,Chandigarh |
|
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Primary Sponsor
|
| Name |
Dr Jagat Ram |
| Address |
|
| Type of Sponsor |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Sushma bhusal,jaspreet sukhija,surinder pandav,sushmita Kkaushik |
|
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagat ram |
PGIMER |
Sec 12,-160012
Chandigarh
CHANDIGARH |
01722756111
drjagatram@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and research,Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pediatric cataract, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AcrySof SA60AT® intra ocular lens (IOL) |
|
| Comparator Agent |
silicone, Tecnis Z9000® IOL |
|
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Inclusion Criteria
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| Age From |
|
| Age To |
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| Gender |
|
| Details |
(a) Children, aged one month to eight years, with visually significant congenital or developmental cataract. (b) Partial or dense, visually significant cataract, involving 3 mm or more of the central visual axis |
|
| ExclusionCriteria |
| Details |
(a) Presence of an associated ocular disease such as microphthalmia, microcornea, glaucoma, uveitis, complicated cataract, posterior lenticonus, coloboma, subluxated lens, retinal lesions like retinal detachment, retinal holes etc. (b) Suspected pre existing posterior capsular defects like traumatic cataract (c) Systemic diseases (d) Children in whom the axial length of the eye < 17mm. |
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| visual axis opacification (VAO), PCO, membranectomy rates for significant VAO |
one year |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="41"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2006 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This prospective clinical study was conducted among children (age 1month to 8 years) with congenital/developmental cataract in a tertiary care centre. The children were randomly divided into two groups. All participants underwent phacoaspiration, primary posterior capsulotomy and anterior vitrectomy. Group A (n=21) was implanted with acrylic hydrophobic, AcrySof SA60AT® intra ocular lens (IOL), where as Group B (n=20) was implanted with silicone, Tecnis Z9000® IOL. The children were evaluated for anterior chamber reaction, IOL position, posterior capsular opacification (PCO), intraocular pressure (IOP), best corrected visual acuity (BCVA), corneal status and refractive errors.Postoperatively, two eyes in each group had significant anterior chamber reaction with fibrin membrane formation. Cornea was clear in both groups. IOLs were in the capsular bag in all but one eye in both groups. Seven eyes in the acrylic group and six eyes in the silicone group achieved visual acuity of 20/40 or better. None of the eye had glaucoma. Best corrected visual acuity (BCVA) at one year was similar in both groups. In the acrylic hydrophobic group, 14 eyes needed hypermetropic correction and 7 eyes were myopic where as in the silicone group 10 eyes had myopia and 10 eyes had hypermetropia at 1 year postoperatively. Posterior capsule opacification at one year postoperative was more common in eyes implanted with acrylic hydrophobic IOL (5 eyes) than in silicone IOL (2 eyes). |