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Selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. This prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (PCCC) with or without anterior vitrectomy (A-Vit) in treating congenital cataracts.
Due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. The major concerned postoperative problem is the after-cataract formation. As a result, PCCC with A-Vit is usually performed to prevent the formation of secondary cataracts. However. Debate over the indication and surgical procedure still persists since A-Vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. Thus, it is necessary to evaluate the safety and effectiveness of PCCC without A-Vit in congenital cataract surgery.
In this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit. PCCC+A-Vit procedure includes anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), PCCC, and A-Vit. Primary intraocular lens implantation (IOL) is performed in children older than age of two. Investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCCC procedure without A-vit | Experimental | Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL |
|
| PCCC+A-Vit procedure | Active Comparator | Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCCC procedure without A-vit | Procedure | In this randomized clinical trial, patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with visual axis opacification | Number of participants with visual axis opacification evaluated based on the retro-illumination. | 5 years |
| Number of participants with uveitis and iris/pupil abnormality | Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination. | 5 years |
| IOP | Intraocular pressure measured by the Tono-pen or non-contact tonometer | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA change | Change from baseline in the best corrected visual acuity (BCVA) measured by the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age. | 5 years |
| AL change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingfeng Qin | Contact | 13724104066 | qintf3@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weirong Chen, MD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| PCCC+A-Vit procedure | Procedure | PCCC+A-Vit procedure |
|
Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
| 5 years |
| CCT change | Change from baseline in the central corneal thickness (CCT) measured by pentacam. | 5 years |
| CFT change | Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT) | 5 years |