| CTRI Number |
CTRI/2016/02/006691 [Registered on: 29/02/2016] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of two methods of cataract surgery on corneal thickness |
|
Scientific Title of Study
|
Central corneal thickness changes in bevel-up versus bevel down phaco-emulsification: A Randomized controlled trial |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Soujanya K |
| Address |
Department of Ophthalmology, Yenepoya Medical College, Yenepoya University, Mangalore-575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964666647 |
| Fax |
|
| Email |
drsoujanyak@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Soujanya K |
| Address |
Department of Ophthalmology, Yenepoya Medical College, Yenepoya University, Mangalore-575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964666647 |
| Fax |
|
| Email |
drsoujanyak@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Soujanya K |
| Address |
Department of Ophthalmology, Yenepoya Medical College, Yenepoya University, Mangalore-575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964666647 |
| Fax |
|
| Email |
drsoujanyak@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Department of Ophthalmology,Yenepoya Medical College Hospital,
Yenepoya University,
Deralakatte,Mangalore-575018,
Dakshin Kannada District,
Karnataka, India |
|
Primary Sponsor
Modification(s)
|
| Name |
Yenepoya Medical College |
| Address |
Yenepoya University,
Deralakatte,Mangalore-575018,
Dakshin Kannada District,
Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soujanya K |
Department of Ophthalmology,Yenepoya Medical College Hospital |
Yenepoya University,
Deralakatte,Mangalore-575018,
Dakshin Kannada District,
Karnataka, India
Dakshina Kannada
|
9964666647
drsoujanyak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Immature cataract |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bevel-down group |
Phacoemulsification will be done using standard protocol (direct chop)with phaco tip being held in the bevel-down position throughout the procedure |
| Intervention |
Bevel-Up group |
Phacoemulsification will be done using standard protocol (direct chop)with phaco tip being held in the bevel-up position throughout the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged >18 years with immature cataract undergoing phacoemulsification at Yenepoya Medical College Hospital, Mangaluru, India and willing to participate in the trial will be selected. |
|
| ExclusionCriteria |
| Details |
History of significant ocular trauma or intraocular surgery, corneal pathology, pseudo-exfoliation syndrome, intraocular inflammation, a preoperative fully dilated pupil smaller than 6 mm , anterior chamber depth less than 2.5mm and nuclear sclerosis grade ≥4. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Central corneal thickness |
Post operative day 1, day 7 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount of irrigating fluid used |
Intra-operative |
| Anterior chamber depth |
Post operative day 1, day 7 and day 30 |
| Corrected distant visual acuity |
Post operative day 1, day 7 and day 30 |
| Effective phaco time |
Intra-operative |
| EFX (Effective phaco time with a specific coefficient for the transversal movement of the phaco tip expressed in seconds) |
Intra-operative |
| Intra-ocular pressure (Central corneal thickness corrected) |
Post operative day 1, day 7 and day 30 |
| Phaco power |
Intra-operative |
| Uncorrected distant visual acuity |
Post operative day 1, day 7 and day 30 |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2016 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
none |
|
Brief Summary
|
Corneal endothelial damage following phacoemulsification is still one of the major concerns of modern day cataract surgery.Several phacoemulsification techniques have been developed and modified. Although many techniques have been proposed, the risks of posterior capsular rupture and corneal endothelium damage persist. In theory, damage to the corneal endothelium is minimized by delivering the lowest phaco energy only in the direction necessary to emulsify the lens nucleus. Hence, it has traditionally been believed, that the bevel of the needle should be turned towards the nucleus or the nuclear fragment (i.e. bevel down). However there is a difference in opinion regarding the phaco tip position and its subsequent effect on corneal endothelium in various studies.Hence this study was planned.
In this study, eligible study participants will be randomised into 2 groups. One group will undergo phacoemulsification with bevel-up technique; and the other group with bevel-down technique. Central corneal thickness will be measured and compared on post operative day1, day 7 and day 30. These will be compared with pre-operative baseline values. Phacoemulsification technique which results in least amount of increase in central corneal thickness will be considered to be more cornea friendly technique.
|
