Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013 Research Foundation Grant | Other Grant/Funding Number | ASCRS Foundation Research Grant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.
This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :
The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.
All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In the bag IOL | Active Comparator | Cataract surgery with IOL implantation in the capsular bag |
|
| Optic Capture of IOL | Active Comparator | intraocular lens implantation in the capsular bag with posterior optic capture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery | Procedure | cataract surgery in children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Posterior capsule opacification requiring surgery | opacification of visual axis | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| inflammation on slitlamp examination | cell depostis | 12 months postoperatively |
| inflammation on slitlamp examination | posterior synechiae |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| abhay vasavada, MS,FRCS | Iladevi Cataract & IOL Research Centre, Ahmedabad, India | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intraocular lens implantation | Procedure | intraocular lens implantation in the capsular bag or optic capture |
|
| 12 months postoperatively |
| intraocular pressure in mmHg | glaucoma | 12 months postoperatively |