| CTRI Number |
CTRI/2024/11/076442 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of additional usage of viscoelastic drug (HPMC 2%) in patients of cataract undergoing phacoemulsification cataract surgery and its outcome on corneal edema: An interventional randomized trial |
|
Scientific Title of Study
|
Effect of Hydroxypropyl Methylcellulose (HPMC 2%) as an Adjuvant in Post Chopping the Nucleus in Phacoemulsification Surgery in Hard Cataract on Corneal Outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhangi SN Prasad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no. 201, Second floor, Eye OPD, AIIMS Campus, Mangalagiri, Guntur
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8868079223 |
| Fax |
|
| Email |
ashubhangi19121997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Balamurugan R |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no. 205, second floor, Eye OPD, AIIMS campus, MAngalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
7087796565 |
| Fax |
|
| Email |
bala.2xyx@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shubhangi SN Prasad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no. 201, Second floor, Eye OPD, AIIMS Campus, Mangalagiri, Guntur
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8868079223 |
| Fax |
|
| Email |
ashubhangi19121997@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Mangalagiri, Mangalagiri, Guntur, Andhra Pradesh - 522503 |
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
201, Eye OPD, AIIMS Mangalagiri, Mangalagiri, Guntur, Andhra Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 Shubhangi SN Prasad |
AIIMS Mangalagiri |
Room no. 201, Eye OPD, AIIMS Mangalagiri, Mangalagiri Guntur ANDHRA PRADESH |
9494905811
ashubhangi19121997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adjuvant HPMC 2% |
Softshell technique (with HPMC 2% followed by NaH 1.4%) with HPMC injection post chopping the nucleus as an adjuvant. |
| Comparator Agent |
without adjuvant HPMC 2% |
Softshell technique without the adjuvant with HPMC 2% injection post chopping the nucleus . |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 50 years.
2. Endothelial count more than 2000 cells/cumm.
3. Patients with nuclear sclerosis, cataract grade of 3 as per Emery Little classification.
4. Patients who is willing to undergo fellow eye cataract surgery for at least one month time
5. Normal macula examination
|
|
| ExclusionCriteria |
| Details |
1. Endothelial cell count less than 2000 cells/cu.mm
2. Patient who comes from far distance and may not able to come for one month follow up.
3. Presence of eye disease like unilateral uveitis, trauma, ICE, glaucoma, raised IOP more than 22 mm Hg, corneal scar, etc.
4. Nuclear sclerosis hard cataract of grade 4.
5. Single eyed.
6. Intumescent and white cataract
7. Any macular diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post treatment parameters measurements at day 1, day 3, day 7 and day 30:
1.BCVA
2.IOP
3.Endothelial cell count
4. corneal oedema grading
5. CCT using AS OCT
|
Post treatment parameters measurements at day 1, day 3, day 7 and day 30.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. corneal oedema grading
2. CCT using AS OCT |
Post treatment parameters measurements at day 1, day 3, day 7 and day 30: |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Back ground and
rational:
Phacoemulsification cataract surgery plus
intraocular ocular lens implantation is a standard of care for the cataract
surgery. There are various techniques of phacoemulsification has been described
like divide and conquer, stop and chop and direct chop. Before emulsifying the
nucleus, the endothelium has to be coated with viscoelastics to protect it from
the ultrasonic energy. The usual loss of endothelium after phacoemulsification
cataract surgery is estimated to be 5-20% at 1- 3 months . There are some
techniques are described like softshell technique i.e., dispersive (HPMC 2%)
followed cohesive, sodium hyaluronate 1.4% (NaH) injection to protect the
endothelium. We feel that during chopping most of the viscoelastic injected was
aspirated during chopping the nucleus and leaving the endothelium less
protective form the phaco ultrasonic energy.
There are many studies which compared the different type of
viscoelastics like HPMC 2%, Discovisc(hyaluronic acid 1.4% / Chondroitin sulphate 4%), viscoat (Sodium hyaluronate 3% / Chondroitin
sulphate 4%)for coating the
endothelium but no studies has compared the effect of coating the endothelium
with dispersive viscoelastic after chopping the nucleus on the corneal outcome
of the phacoemulsification surgery.
Ocular viscoelastic devices (OVD) are very
helpful in the cataract surgery. There are various forms of OVDs are available
with cohesive property (Sodium hyaluronate 1.4% ) and dispersive property
(HPMC2%). Cohesive OVDs are more of solid in nature when injected into the
anterior chamber forms the good work place for the intraocular instruments
whereas the dispersive OVDs are more of liquid in nature which coats the
endothelium better. There are various studies have compared the efficacy of
different types of OVDs in the phacoemulsification cataract surgery.Espı´ndola RF et al have
compared the efficacy of Discovisc (hyaluronic acid 1.4% / Chondroitin sulphate
4%) with HPMC 2%; Vajpayee et al have
compared Healon GV (Sodium hyaluronate 1.4%) , Healon 5 (Sodium hyaluronate
2.3%), Viscoat (Sodium hyaluronate 3.0% / Chondroitin sulphate 4%); Maár et
al.compared Healon (Sodium hyaluronate 1%) and Viscoat (Sodium hyaluronate
3% / Chondroitin sulphate 4%); Storr-Paulsen et al have compared the celoftal
(HPMC 2%), vitrax (Sodium hyaluronate 3% ) and Healon (Sodium hyaluronate 1%).
They have all compared the different type of OVDs before the start of the
phacoemulsification.
Novelty/Innovation:
We have realised that some additional
dispersive OVDs are needed in the middle of phacoemulsification to coat the
endothelium again as most of the OVDs will be aspirated during the initial part
of the phacoemulsification. So, we have designed this study to show the
efficacy of adjuvant coating of endothelium using HPMC 2% in the middle of the
phacoemulsification process i.e., after chopping into multiple pieces and after
removing of the half of the nucleus.
Hypothesis/Research
question:
1. Is the additional
or adjuvant coating of HPMC 2% in the middle of the phacoemulsification helpful
for decreasing the corneal oedema and improve the post operative corneal
outcome? |