| CTRI Number |
CTRI/2025/02/080662 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study between primary iris claw intraocular lens fixation versus secondary iris claw Intraocular lens fixation after posterior capsular rupture |
|
Scientific Title of Study
|
Primary iris claw intraocular lens fixation versus secondary iris claw Intraocular lens fixation for visual outcome after posterior capsular rupture: A Randomised Controlled 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 |
Dr Tahir Husain Ansari |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 1069-A, Department of Ophthalmology, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9012355563 |
| Fax |
|
| Email |
drtahir08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tahir Husain Ansari |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 1069-A, Department of Ophthalmology, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9012355563 |
| Fax |
|
| Email |
drtahir08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjali Seth |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 1069-B, Department of Ophthalmology, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7007587763 |
| Fax |
|
| Email |
arginine84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital
Pilibhit bypass road
Bareilly
243006
UTTAR PRADESH
INDIA |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital Pilibhit bypass road Bareilly 243006 UTTAR PRADESH INDIA |
| Type of Sponsor |
Private 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 tahir |
Rohilkhand Medical College and Hospital |
Room No 1069-A
Department of Ophthalmology,
Rohilkhand Medical College and Hospital
Philibhit bypass road
Bareilly
243006
UTTAR PRADESH
Bareilly
UTTAR PRADESH |
9012355563
drtahir08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
iris claw lens |
iris claw intraocular lens will be placed retropupillary area in case of posterior Capsular Rent |
| Intervention |
Iris claw lens |
Iris claw lens will be placed in the retropuppilary area of pt left aphakic due to posterior capsular rupture |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All cataract surgeries complicated due to Posterior Capsular Rupture (PCR)
2.All aphakic patients with no capsular support and patients with Posterior Capsular Rupture (PCR) who have undergone Cataract Surgery, where Posterior Chamber Intra Ocular Lens implantation is not possible.
|
|
| ExclusionCriteria |
| Details |
1.Patients with no perception of light and defective projection of rays (PR).
2.Significant iris pathology (iris atrophy, iris cyst, aniridia).
3.Glaucoma.
4.Chronic or recurrent uveitis/ iritis.
5.Diagnosed case of systemic hypertension with signs of retinopathy.
6.Severe diabetic eye disease.
7.Corneal pathology: Corneal scarring, irregularities or opacities.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Best Corrected Visual Acuity(BCVA)
2. IOP
3.Pupil Shape |
1.Best Corrected Visual Acuity(BCVA) on day1 wk1 month1
2. IOP day1 wk1 followed by weekly readings if raised
3.Pupil Shape day1 wk1 month1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hyphema
2. AC cells
3. AC flair
4. Astigmatism
|
1.Hypehma if present will be seen on Day 1
2.AC cells and flair will have to be seen on 1st week, if present then to be called every week for 1 month else not than on monthly basis for 3 months.
4.Astigmatism should be seen after 1 month.
|
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
17/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Cataract surgeries are one of the most common ocular surgeries, in which some complications are bound to happen. One among them being posterior capsular rupture in which patients may remain aphakic in many cases. Thus, with the introduction of iris claw lenses, these patients gained BCVA of 6/18 or better according to previous studies conducted. iris claw lenses can be placed retropupillary in the non reacting zone of the pupil.
In this study, we will be comparing iris claw lenses implantation within the primary sitting or if done after 6 weeks, for vision, IOP and pupil shape.
|