The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

Microspherophakia Clinical Trial

Official title:

The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447157
• Other study ID #: xuwen2020-465
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: June 20, 2020

Study information

• Verified date: June 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 20, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Inclusion Criteria:

• Microspherophakia was diagnosed and lens diameter<9mm;

• The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;

• Lens dislocated into the anterior chamber;

• Lens dislocation caused elevated intraocular pressure (IOP);

• The lens contacted the corneal endothelium;

• Cataract;

• Corneal endothelial cell density>1000/mm2;

• The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy;

• There was possible improvement in postoperative visual acuity measured by retinometer.

Exclusion Criteria:

• The lens is centered and the position of the lens is stable;

• Glasses can correct the vision obviously;

• The reason for the elevated IOP was independent with the lens;

• A high possibility of corneal decompensation after surgery;

• Fundus function was poor and it is not expected to improve the vision after surgery;

• Combined with other ocular diseases which were not suitable for IOL implantation;

• Combined with a systemic disease that the patient cannot tolerate the surgery.

Related Conditions & MeSH terms

• Corneal Diseases
• Ectopia Lentis
• Glaucoma
• Microspherophakia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	6 month postoperation
Primary	Visual function	uncorrected distance visual acuity (UDVA) measured using a decimal chart	6 month postoperation
Primary	Intraocular pressure	intraocular pressure measured using non-contact tonometer	6 month postoperation
Primary	PCIOL tilt degree	PCIOL tilt degree measured using Ultrasound biomicroscope	6 month postoperation
Primary	PCIOL decentration distance	PCIOL decentration distance measured using Ultrasound biomicroscope	6 month postoperation
Primary	Endothelial cell density	Endothelial cell density was measured by specular microscopy	6 month postoperation
Primary	Anterior chamber depth	Anterior chamber depth measured using Ultrasound biomicroscope	6 month postoperation