| CTRI Number |
CTRI/2015/09/006191 [Registered on: 16/09/2015] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing performance and outcomes of traditional phaco vs. laser assisted phaco in eyes with narrow anterior segment cataract. |
|
Scientific Title of Study
|
Intraoperative performance and postoperative outcomes following femtosecond laser assisted cataract surgery (FLACS) and manual phacoemulsification in eyes with shallow anterior chambers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
Gurukul Road, Memnagar,
Drive In Branch
Ahmadabad
GUJARAT
380052
India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
Gurukul Road, Memnagar,
Drive In Branch
Ahmadabad
GUJARAT
380052
India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
Gurukul Road, Memnagar,
Drive In Branch
Ahmadabad
GUJARAT
380052
India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
|
Source of Monetary or Material Support
|
| Alcon Laboratiores Inc, 6201 , South freeway ,Fort Worth , Texas 76134 |
|
|
Primary Sponsor
|
| Name |
Alcon Laboratories Inc |
| Address |
6021, South freeway Fortworth,Texas 76134, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Vasavada |
Raghudeep Eye Hospital |
Drive in Branch, Gurukul road , Memnagar
Ahmadabad
GUJARAT |
40400909
icirc@abhayvasavada.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Iladevi Cataract and IOL Research CEntre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients undergoing phacoemulsification for age-related cataracts and have a shallow anterior chamber., (1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femto laser assisted cataract surgery |
. Femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. By performing the corneal incisions, anterior capsulorhexis and lens fragmentation, the effective phacoemulsification time and intra-operative manipulation is greatly reduced in FLACS |
| Comparator Agent |
Phaco emulsification traditional |
It is known that phacoemulsification in small eyes can be difficult and challenging. Phacoemulsification in eyes with a shallow anterior chamber (ACD 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet’s detachment and iris prolapse. A shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult male or female patients requiring cataract surgery at least in one eye
|
|
| ExclusionCriteria |
| Details |
Coexisting ocular morbidity, inability to come for followup |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Corneal thickness measured by ultrasonic pachymetry on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).
|
Corneal thickness measured by ultrasonic pachymetry on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anterior chamber cells, Presence of Descemats folds, Presence of Descemats detachment,Percentage change in endothelial cell, Iris damage on slit lamp examination, unaided visual acuity, best corrected distance visual acuity, surgeons grading of intraoperative difficulty |
1 week, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="182"
Sample Size from India="182"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aims to compare intraoperative performance and post operative outcomes following femtosecond laser assisted phacoemulsification vs. traditional phacoemulsification in eyes with age related cataract and shallow anterior chamber. |