| CTRI Number |
CTRI/2024/04/066490 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Does additional steroid help improve success in glaucoma surgery |
|
Scientific Title of Study
|
The effect of additional versus no preoperative topical steroids on trabeculectomy outcomes in Indian eyes- a randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parivadhini Annadurai |
| Designation |
Senior consultant |
| Affiliation |
Medical research foundation, Sankara Nethralaya |
| Address |
Department: Smt Jadhavbai Nathmal Singhvee glaucoma services, Medical research foundation, Sankara Nethralaya, No 41(old 18), College road, Nungambakkam, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
04428271616 |
| Fax |
|
| Email |
drap@snmail.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Parivadhini Annadurai |
| Designation |
Senior consultant |
| Affiliation |
Medical research foundation, Sankara Nethralaya |
| Address |
Department: Smt Jadhavbai Nathmal Singhvee glaucoma services, Medical research foundation, Sankara Nethralaya, No 41(old 18), College road, Nungambakkam, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
04428271616 |
| Fax |
|
| Email |
drap@snmail.org |
|
Details of Contact Person
Public Query
|
| Name |
Parivadhini Annadurai |
| Designation |
Senior consultant |
| Affiliation |
Medical research foundation, Sankara Nethralaya |
| Address |
Department: Smt Jadhavbai Nathmal Singhvee glaucoma services, Medical research foundation, Sankara Nethralaya, No 41(old 18), College road, Nungambakkam, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
04428271616 |
| Fax |
|
| Email |
drap@snmail.org |
|
|
Source of Monetary or Material Support
|
| Medical research foundation, Sankara Nethralaya, No 41(old 18), College road, Nungambakkam, Chennai, Tamil Nadu,India PIN-600006 |
|
|
Primary Sponsor
|
| Name |
Medical research foundation, Sankara Nethralaya |
| Address |
No 41(old 18), College road, Nungambakkam, Chennai, Tamil Nadu , 600006
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Parivadhini Annadurai |
Sankara Nethralaya |
Department: Smt Jadhavbai Nathmal Singhvee glaucoma services, Medical research foundation, No 41(old 18), College road, Nungambakkam, Chennai, Tamil Nadu , 600006
Chennai
TAMIL NADU |
04428271616
drap@snmail.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institiutional review board- Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluromethalone 0.1% |
Additional use of fluoromethalone 0.1% eye drops one drop 4 times per day for 7 days (± 2 days) prior to surgery |
| Comparator Agent |
Nil additional steroid |
No use of additional steroids preoperatively |
| Intervention |
Prednisolone acetate 1% |
Additional use of prednisolone acetate 1% eye drops one drop 4 times per day for 7 days (± 2 days) prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Primary glaucoma on topical IOP lowering medication for at least 6 months
Glaucoma not controlled on medical therapy
Patient intolerant to topical IOP lowering medication for IOP control
Glaucoma controlled on medical therapy but patient with more than two IOP lowering medication undergoing cataract surgery
Age atleast eighteen years or older
Snellen best corrected visual acuity of 6/60 or better |
|
| ExclusionCriteria |
| Details |
Any patient with uncontrolled IOP and glaucomatous damage requiring surgical intervention at the earliest and hence unable to take the preoperative topical steroid course
Active severe inflammation requiring topical steroids within the last 3 months
History of Yttrium Aluminum Garnet peripheral iridotomy (YAG PI) within the last 3 months
Those with history of laser trabeculoplasty
Prior surgery other than uncomplicated clear corneal phacoemulsification
Other ocular pathology including retinal pathology, uveitis
Secondary glaucoma including but not limited to steroid induced glaucoma, ICE syndrome, pseudoexfoliation glaucoma, pigment dispersion syndrome, neovascular glaucoma
History of ocular trauma in the eye planned for trabeculectomy
Myopia more than 6D/ pathological myopia
One eyed patients
Pregnant or nursing women
Concurrent or steroid use within last 3months for other diseases |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete success- IOP of greater than or equal to 6mmHg or less than or equal to 18 mmHg on Goldmann applanation tonometry, without the need for additional medication or procedure for IOP control, or vision threatening complications (endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etc)
|
6 weeks, 4-5 months and 10-12 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Qualitative and quantitative assessment of ocular fluid and tissue for inflammatory markers among the three groups (in a subset) |
At enrollment(tear sample) and on day of surgery (ocular fluid and tissue) |
| Qualified success: additionally includes those with the criteria for success but additionally includes those with IOP control obtained on use of on IOP lowering medication also |
6 weeks, 4-5 months and 10-12 months |
| Number of medications used for IOP control |
6 weeks, 4-5 months and 10-12 months post surgery |
| Atleast 3 point total difference on bleb assessment of photograph |
6 weeks, 4-5 months and 10-12 months post surgery |
| Failure defined as IOP of less than 6 or greater than 18 mmHg on Goldmann applanation tonometry, need for additional procedure for IOP control, or vision threatening complications like endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etc |
6 weeks, 4-5 months and 10-12 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
11/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
| This
study is a randomized, outcome assessor blinded, parallel group,
single-centre trial comparing efficacy of preoperative topical steroid drops
(prednisolone acetate 1% or Fluorometholone 0.1%) versus no preoperative
topical steroids in primary glaucoma patients planned for surgery. Outcome
will be primarily assessed in terms of complete success.
Additionally, the qualified success, failure rates, inflammatory markers (for a subset), bleb
characteristics in these three groups will also be compared |
|