| CTRI Number |
CTRI/2024/02/062394 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare results of two different cataract surgeries along with glaucoma surgery in patients with cataract and glaucoma |
|
Scientific Title of Study
|
A Small incision cataract surgery trabeculectomy with phacoemulsification trabeculectomy - 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 SRISHTI JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 3108 DEPARTMENT OF OPHTHALMOLOGY ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8979141020 |
| Fax |
|
| Email |
srjn27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHUTOSH DOKANIA |
| Designation |
HEAD OF DEPARTMENT PROFESSOR |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 3108 DEPARTMENT OF OPHTHALMOLOGY ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9897294857 |
| Fax |
|
| Email |
ashutoshdokania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SRISHTI JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 3108 DEPARTMENT OF OPHTHALMOLOGY ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8979141020 |
| Fax |
|
| Email |
srjn27@gmail.com |
|
|
Source of Monetary or Material Support
|
| 4 PILIBHIT BYPASS ROAD PAWAN VIHAR Rohilkhand Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
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 SRISHTI JAIN |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF OPHTHALMOLOGY ROOM NO 3108
Bareilly
UTTAR PRADESH |
8979141020
srjn27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RMCH BAREILLY U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
na |
| Intervention |
SURGICAL |
Patients with significant cataract and coexisting primary open angle glaucoma will be examined and divided into 2 groups randomly group A will undergo Small incision cataract surgery trabeculectomy and group B undergo phacoemulsification trabeculectomy |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with significant cataract and coexisting primary open angle glaucoma.
Patients with Age group more than 50years |
|
| ExclusionCriteria |
| Details |
Patients with other secondary glaucoma like Pseudoexfoliative glaucoma, Pigmentary glaucoma, neovascular glaucoma and inflammatory glaucoma.
Patients who underwent other surgical glaucoma treatments previously.
Patients with previous Ocular trauma or surgery.
• Patients with complicated cataract.
• Patients with systemic diseases such as Diabetes Mellitus and Hypertension. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to analyse visual field outcome and intraocular pressure preoperative and postoperative in both surgeries |
1 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze stability in Ganglion cell complex on Optic coherence tomography & field changes on Humphreys Perimetery preoperative & after 3 months postoperative |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Glaucoma and cataract follow a silent and highly variable natural course and the most common causes of visual handicap in senescence. the presence of cataract can affect the ability to assess glaucoma progression, and cataract extraction affects intraocular pressure as well as effectiveness of glaucoma surgery. Combined procedures reduces the hospital stay and health expenditure of the individual. As limited number of studies are being available on the comparison between SICS Trabeculectomy vs Phacoemulsification trabeculectomy on the patients with the coexisting cataract and open angle glaucoma Hence, to aid in early detection and treatment & to fill the vaccum of knowledge this study is being conducted,All patients coming to Eye OPD of age more than 50 years (RMCH) with coexisting cataract and glaucoma at fulfilling the inclusion and exclusion criteria.Size is statistically calculated by using the software Power and sample size program. The calculated sample size is 36 in each group. A total of 72 patients will be taken. After taking approval from the Institutional Ethical Committee, this study will be conducted by recruiting the patients, qualifying the inclusion as well as the exclusion criteria. All the patients reporting at the OPD at Rohilkhand Medical College and Hospital, Bareilly with coexisting cataract and glaucoma will be selected and divided into 2 groups randomly. Group A patients will undergo Small Incision Cataract Surgery Trabeculectomy and Group B- patients will undergo Phacoemulsification Trabeculectomy. A written and informed consent will be taken they will be evaluated thoroughly preoperatively.The patients will be reviewed at 1st day postoperative then will be assessed on 3 visits (1week, 4weeks and 12 weeks postoperative). At each visit IOP assessment, BCVA, slit-lamp examination, fundus examination. Anterior chamber, intra ocular lens and wound assessment will be done.At 12th week OCT will be done to assess the stability of peripapillary and macular GCC thickness Humphrey’s Perimetery will be done to analyse visual field changes.. The data will be entered in the Eoi InfoTM 7.1.5 Descriptive analysis will be done calculating proportions, means & standard deviation. Aprropriate statistical test will be applied depending on type & the distribution and type of data. P<0.05 will be considered significant.conclusion will be made that which amongstthe two procedure is better. |