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Influence of Different Tamponade Eyes on IOL-capsular Complex

W

Wenzhou Medical University

Status

Unknown

Conditions

Vitreoretinal Abnormality
Cataract

Treatments

Procedure: phacovitrectomy surgery with balanced saline solution tamponade
Procedure: phacovitrectomy surgery with gas tamponade
Procedure: phacoemulsifacation surgery without vitrectomy
Procedure: phacovitrectomy surgery with silicone oil tamponade

Study type

Interventional

Funder types

Other

Identifiers

NCT05296486
IOL with different tamponade

Details and patient eligibility

About

Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery.A combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil(SO),gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes,gas filled eyes, balanced saline solution filled eyes and normal eyes.

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity.

Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality.

Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Full description

Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery. Although the optimal treatment for patients with both vitreoretinal and cataract disease is still a matter of debate, a combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil(SO),gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. As a biochemically inert polymer, SO is widely used in vitreoretinal surgery and was considered to be well-tolerated and not threatening to retinal physiology. The gases in therapeutic use ([SF6], [C2F6], or [C3F8]) may be mixed with air in vitrectomy or used as 100% gas in pneumatic retinopexy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes,gas filled eyes, balanced saline solution filled eyes and normal eyes.

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity.

Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality.

Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Enrollment

100 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patients are diagnosed age related cataract or complicated cataract with or without vitreoretinal diseases
  • The patients' age over 50 years old
  • The patients plan to receive cataract surgery with or without vitrectomy in Eye hospital of Wenzhou Medical University
  • The dilated pupils are over 7mm
  • Patients are willing and able to complete the follow-ups.

Exclusion criteria

  • Patients with other type of cataract
  • Patients have severe complications in the surgery and after surgery
  • Patients have other severe diseases of eyes

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 4 patient groups

phacovitrectomy surgery with silicone oil tamponade
Experimental group
Description:
patients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50.
Treatment:
Procedure: phacovitrectomy surgery with silicone oil tamponade
phacovitrectomy surgery with gas tamponade
Experimental group
Description:
patients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50.
Treatment:
Procedure: phacovitrectomy surgery with gas tamponade
phacovitrectomy surgery with balanced saline solution tamponade
Experimental group
Description:
patients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50.
Treatment:
Procedure: phacovitrectomy surgery with balanced saline solution tamponade
phacoemulsifacation surgery without vitrectomy
Experimental group
Description:
patients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50.
Treatment:
Procedure: phacoemulsifacation surgery without vitrectomy

Trial contacts and locations

0

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Central trial contact

Pingjun Chang; Yune Zhao, MD

Data sourced from clinicaltrials.gov

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