| CTRI Number |
CTRI/2022/12/048248 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
14/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Other (Specify) [INTRAOCULAR LENS IMPLANTATION] |
| Study Design |
Other |
|
Public Title of Study
|
VISUAL OUTCOME AFTER CATARACT SURGERY |
|
Scientific Title of Study
|
REFRACTIVE OUTCOME OF CILIARY SULCUS IMPLANTED INTRAOCULAR LENSES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR LEKSHMY M S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH
KOLAR
KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
9995281075 |
| Fax |
|
| Email |
lekshmyaravind21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANGEETHA T |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH
KOLAR
KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
9880031831 |
| Fax |
|
| Email |
sangeetha31jayakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANGEETHA T |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH
KOLAR
KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
9880031831 |
| Fax |
|
| Email |
sangeetha31jayakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
KOLAR
KARNATAKA
INDIA
563101 |
| 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 LEKSHMY M S |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION |
NO: 22, DEPARTMENT OF OPHTHALMOLOGY, FIRST FLOOR,
R. L. JALAPPA HOSPITAL & RESEARCH,
TAMAKA, KOLAR -563101
Kolar
KARNATAKA |
9995281075
-
lekshmyaravind21@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DEVARAJ URS MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CATARACT SURGERY |
Routine small incision cataract surgery or phacoemulsification will be performed through a sclerocorneal tunnel. The IOL power will be reduced by 0.5 or 1 D from the IOL power calculated by the SRK-II formula for in-the-bag implantation. The decision to reduce IOL power will be at the discretion of the operating surgeon. Postoperatively patients will be instructed to instill steroid antibiotic eye drops for 6 weeks in a tapering dose and followed up at day 1, day 7 and 1 month for Spherical Equivalent Refraction and complications. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Capsule rupture:
a) Anterior capsular tear without extension
b)Anterior capsular tear extending to posterior capsule
c) Posterior capsular tear with intact anterior capsule
2. Zonular dehiscence
3. Weak zonules in case of pseudoexfoliation
4. Uveitis
5. Traumatic subluxation of lens |
|
| ExclusionCriteria |
| Details |
1. Lack of Anterior Capsular Support
2. Patients on any topical IOP-lowering drugs like Timolol.
3. Patients with lacrimal gland and drainage disorder.
4. History of any ocular surface surgery or ocular trauma.
5. Patients with diabetes mellitus.
6. Thyroid disease patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in the preoperative predicted and postoperative spherical equivalent refraction for each patient - “Refractive shift†|
To determine the difference in the preoperative predicted and postoperative spherical equivalent refraction for each patient at day 1, day 7 and after 1 month postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the difference in the IOL power for in the bag implantation and for the IOL implanted in the ciliary sulcus
2. To document any intraoperative and postoperative complications |
One month |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
Final Enrollment numbers achieved (Total)= "77"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2022 |
| Date of Study Completion (India) |
20/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sent for publication, under review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Purpose: Although in-the-bag intraocular lens (IOL) implantation provides the most physiologic positioning and favourable long-term stability, ciliary sulcus placement is preferred in cases of posterior capsule compromise or zonular weakness. This study aims to evaluate differences between predicted and postoperative spherical equivalent refraction, as well as IOL power requirements, in in-the-bag versus ciliary sulcus implantation techniques. MATERIALS AND METHODS This prospective interventional study included 77 patients who underwent cataract surgery over the past 18 months. Preoperative visual acuity, axial length, predicted intraocular lens (IOL) power using the SRK/T formula, and predicted refraction were recorded. Postoperative visual acuity and refraction were also assessed. For each patient, the difference between predicted and postoperative refraction for in-the-bag IOL implantation was calculated. RESULTS: A total of 77 patients (20 males, 57 females) with a mean age of 63.50 ± 10.45 years were included. Mean preoperative and postoperative BCVA improved from 1.039 ± 0.745 to 0.189 ± 0.177 logMAR (P < 0.001). The mean predicted and postoperative spherical equivalent were 0.0108 ± 0.009 and 0.0586 ± 0.177, respectively (P < 0.001). The mean virtual IOL power was 21.50 ± 1.96 D, compared with an implanted IOL power of 22.05 ± 1.94 D (P < 0.001). CONCLUSION: Ciliary sulcus implantation of IOLs in eyes with posterior capsular defects resulted in significant visual improvement with no major complications. However, differences between predicted and postoperative refraction highlight the need for appropriate IOL power adjustment and careful case selection. Longer-term studies are required to confirm safety and refractive stability.
|