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This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, IOL position, and postoperative complications will be compared between eyes.
Patients with retinitis pigmentosa (RP) have a higher risk of developing cataracts, often accompanied by abnormalities such as zonular laxity and vitreous liquefaction, which increases the risk of intraocular lens (IOL) tilt, decentration, and capsular contraction after surgery. The capsular tension ring (CTR) can support the zonules and maintain the stability of the capsular bag, but its effect in RP patients remains controversial.
In this self-controlled clinical trial, we are going to recruit 88 RP patients scheduled for bilateral cataract surgery. Both eyes receive a monofocal DCB00 IOL, while only on eye receives an additional CTR. Follow up visits take place 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. At the follow up visits, IOL decentration and tilt (determined by anterior segment SS-OCT Casia 2), visual acuity, and postoperative complications will be compared intraindividually at different timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group: IOL Plus CTR implantation | Experimental | Patients will undergo phacoemulsification combined with IOL and CTR implantation |
|
| Control Group: IOL implantation Only | No Intervention | Patients will undergo phacoemulsification combined with IOL implantation. All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL (J&J Tecnis DCB00) is implanted in the capsular bag. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTR implantation | Procedure | Device: CTR (275001G, OPHTEC BV, Netherlands) All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, a capsular tension ring is implanted in the capsular bag and then IOL (J&J Tecnis DCB00) is implanted. |
| Measure | Description | Time Frame |
|---|---|---|
| IOL dencentration | Measured by anterior segment OCT (CASIA2) | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| IOL dencentration | Measured by anterior segment OCT (CASIA2) | Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery |
| IOL tilt | Measured by anterior segment OCT (CASIA2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuke Pan, Master | Contact | 8613060768121 | 1693156383@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuhua Tan, PhD | 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 | 510623 | China |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
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This is an intraindividual comparative study. Each participant receives bilateral cataract surgery, with one eye randomly assigned to CTR implantation and the other eye without CTR.
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|
| Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery |
| BCVA | BCVA is evaluated with ETDRS visual acuity chart. | Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery |
| Postoperative complications | Postoperative complications such as posterior capsular opacification, anterior capsule contraction, cystoid macular edema are examined by slit lamp photograph and other devices if necessary. | 1 week, 1 month, 3 months, 6 months, 1 year after surgery |
| Shenzhen Eye Hospital | Not yet recruiting | Shenzhen | Guangdong | 518040 | China |
|
| Wuhan Aier Eye Hospital | Not yet recruiting | Wuhan | Hubei | 430061 | China |
|
| D012162 |
| Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |