| CTRI Number |
CTRI/2023/12/060684 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare lens and iris paramters of eye in different types of glaucoma using octical coherence tomography investigation |
|
Scientific Title of Study
|
Lens and Iris parameters in angle-closure spectrum post iridotomy on
Anterior Segment Optical Coherence Tomography |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saksham mathur |
| Designation |
Junior resident |
| Affiliation |
Maulana azad medical college |
| Address |
Department of ophthalmology, Guru nanak eye centre, maharaja ranjit singh marg
New Delhi
DELHI
110002
India |
| Phone |
09540619437 |
| Fax |
|
| Email |
Mathur.saksham98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Singh |
| Designation |
Head of department |
| Affiliation |
Maulana azad medical college |
| Address |
Department of ophthalmology, guru nanak eye centre
New Delhi
DELHI
110002
India |
| Phone |
9540619437 |
| Fax |
|
| Email |
Mail4kirti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saksham mathur |
| Designation |
Junior resident |
| Affiliation |
Maulana azad medical college |
| Address |
Guru nanak eye centre , maharaja ranjjt singh marg
New Delhi
DELHI
110002
India |
| Phone |
09540619437 |
| Fax |
|
| Email |
Mathur.saksham98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college,bahadur shah zafar marg, new delhi |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
Maharaja ranjit singh marg, new delhi |
| 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 saksham mathur |
Guru nanak eye centre |
Department of ophthalmology, Maharaja ranjit singh marg, new delhi
Central
DELHI |
9540619437
Mathur.saksham98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open angle non glaucomatous patients |
Control group will undergo only phacoemulsification |
| Intervention |
Phacoemulsification or Phaco emulsification combined with Trabeculectomy |
Patients will undergo either Phacoemulsification or Phaco combined with trabeculectomy and will be followed up at 1 wekk, 1 month and 4 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Study: ACG patients
Control: non glaucomatous |
|
| ExclusionCriteria |
| Details |
1.Ocular pathology like uveitis or trauma.
2. Prior intraocular surgery.
3. Pregnancy/ patients on hormone replacement therapy
4. Zonular instability
Outcomes Evaluated |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lens & iris parameters in angle closure glaucoma post iridotomy vs control group |
Baseline
1 week
1 month and
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of Iris parameters pre and post lens surgery and correlating it with Intra
ocular pressure reduction.
• Comparison of degree of Iridotrabecular contact pre and post lens surgery and
correlating it with Intra ocular pressure reduction |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/12/2023 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Mathur.saksham98@gmail.com].
- For how long will this data be available start date provided 24-11-2024 and end date provided 24-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Written informed consent from each patient for enrolment. All patients will undergo AS-OCT (CASIA2; Tomey, Nagoya, Japan) imaging in a semi-dark room by an experienced single operator. The scans will be centred on the pupil; two cross-sectional horizontal (nasal-temporal angles: 0-180 degree) and vertical (superior-inferior angles: 90-270 degree) scans will be evaluated. Surgery (Clear corneal phacoemulsification) will be performed by a single experienced surgeon . Only uncomplicated cataract surgery cases would be included Collected data will be entered in Microsoft Excel , analysed & statistically evaluated using SPSS 25 software.
|