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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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?

 
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