| CTRI Number |
CTRI/2025/09/094221 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
High Eye PressureS due to Cataracts - What is it and How it affects your vision |
|
Scientific Title of Study
|
Comprehensive evaluation of clinical characteristics and visual outcomes in Lens Induced Glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruv Mahajan |
| Designation |
PG Resident |
| Affiliation |
Sankara Eye Hospital , Pedakakani , Guntur |
| Address |
Room Number 135 ,Glaucoma Department , Sankara eye hospital , Guntur-vijaywada highway, Pedakakani , Guntur Andhra Pradesh, 522509, India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8800934735 |
| Fax |
|
| Email |
dhruvmahajan99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srilakshmi Sikhakolli |
| Designation |
Consultant , Glaucoma |
| Affiliation |
Sankara Eye Hospital , Pedakakani , Guntur |
| Address |
Room Number 135 ,Glaucoma Department , Sankara eye hospital , Guntur-vijaywada highway, Pedakakani , Guntur Andhra Pradesh, 522509, India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9348422144 |
| Fax |
|
| Email |
srilakshmi@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Srilakshmi Sikhakolli |
| Designation |
Consultant , Glaucoma |
| Affiliation |
Sankara Eye Hospital , Pedakakani , Guntur |
| Address |
Room Number 135 ,Glaucoma Department , Sankara eye hospital , Guntur-vijaywada highway, Pedakakani , Guntur Andhra Pradesh, 522509, India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9348422144 |
| Fax |
|
| Email |
srilakshmi@sankaraeye.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dhruv Mahajan |
| Address |
Room Number 135 ,Glaucoma Department , Sankara eye hospital , Guntur-vijaywada highway, Pedakakani , Guntur Andhra Pradesh, 522509, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhruv Mahajan |
Sankara Eye Hospital , Guntur |
Room Number 135 ,Glaucoma Department , Sankara eye hospital , Guntur-vijaywada highway, Pedakakani , Guntur Andhra Pradesh, 522509, India
Guntur
ANDHRA PRADESH |
8800934735
dhruvmahajan99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Sankara Eye Hospital Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H405||Glaucoma secondary to other eye disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who will be diagnosed of having lens induced glaucoma by the following criteria
Cataract associated with an acute rise in intraocular pressure to cause clinical signs and symptoms
Slit lamp examination to diagnose the type of lens induced glaucoma
Patients who signed a written and informed consent for the surgery and also for the study will be included |
|
| ExclusionCriteria |
| Details |
Prexisting primary glaucoma
Patients with co-incident cataract and glaucoma
Other secondary glaucoma such as due to trauma , inflammation or neovascular glaucoma
Abnormal pigment deposition in the anterior chamber mainly pigment dispersion, pseudoexfoliation
Patients unfit for surgery due to poor general condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the visual outcomes, intraocular pressure , and optic disc changes post management of lens induced glaucoma with respect to the time of presentation of patients and the type of lens induced glaucoma |
Clinical examination at presentation and post operative follow up at 1 week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2025 |
| 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="6"
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
|
Lens induced glaucoma is a group of secondary glaucomatous disorders having influence of lens or its by products in its pathogenesis of elevated intraocular pressure and optic disc damage . This study aims at understanding the presentation , causes and management of lens induced glaucoma . The purpose of this study is to evaluate the visual outcomes , intraocular pressure and optic disc changes post management , with respect to the time of presentation and the type of lens induced glaucoma . Intraoperative and Postoperative complications will also be evaluated . This study is a longitudinal prospective study done at a tertiary eye care hospital , and will be done between august 2025 to february 2027. Patients who sign an informed written consent and satisfy the inclusion and exclusion criteria will be accepted for the study. |